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Use of Dietary Supplements by Military Personnel Summary To achieve and maintain optimal readiness and mission performance goals, the military has the responsibility of guiding its service members in making choices that best enhance their health, including nutrition. As with other sectors of the population, the use of dietary supplements to promote health has become increasingly popular among members of the military, which faces a paradox in managing their use. Supplements available to service members range from those that might impart beneficial effects to health and performance with negligible side effects to others that have uncertain benefits and might be potentially harmful to health and performance. Furthermore, the military, cognizant of the potential benefits of dietary supplements, is conducting research on some promising supplements; in these cases, the potential for adverse effects should also not be underestimated. Without appropriate guidance on their use, military service members might not only compromise their own performance or health and the success of military operations, but might also forego dietary supplements with potential to improve performance or health. There are no servicewide military policies (e.g., education or regulations) to guide commanders in management practices for safe use of dietary supplements; furthermore, there is no formal military pathway to report adverse events potentially associated with dietary supplements. The lack of consistent policies for the safe use of dietary supplements has raised concerns owing to the vulnerabilities of some military subpopulations. Previous Institute of Medicine (IOM) reports prepared under the auspices of the Committee on Military Nutrition Research (CMNR) have found that nutritional needs of military service members differ from those of civilians, de-
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Use of Dietary Supplements by Military Personnel pending on the specific subpopulation, the mission, and the environmental circumstances. Thus, the effects of dietary supplements, whether beneficial or detrimental, might be different for military service members, specifically for some subpopulations facing heightened risks (e.g., Special Forces, Rangers, aviators). Perhaps more importantly, even minor detriments to health that represent simply discomfort or inconvenience to a civilian (e.g., mild dehydration or mild diarrhea) might compromise a service member’s performance or health and, thus, the success of the military operation. The regulatory responsibility of the U.S. Food and Drug Administration (FDA) for the safety of dietary supplements is designated by the 1994 Dietary Supplement Health and Education Act. Actions to restrict the availability of a dietary supplement must proceed from a demonstration by the FDA of a significant or unreasonable risk of illness or injury to consumers under conditions of recommended use. Manufacturers are responsible for ensuring the safety of the ingredient, but the FDA is not authorized by statute to require data supporting safety, as is the case for food additives or drugs. This approach may not be sufficient to ensure the safe use of dietary supplements in some military contexts, which inherently present considerable risk to individuals. Based on the heightened risks, potential for benefits, frequency of use among military service members, the lack of consistent policies, and the absence of an internal process to report adverse events as they occur in military settings, the Department of Defense (DoD), Samueli Institute, and National Institutes of Health, with additional support from the FDA, requested that the IOM convene an ad hoc committee under the oversight of the CMNR. The Committee on Dietary Supplement Use by Military Personnel was asked to review the patterns of dietary supplement use among military personnel, to recommend a framework to identify the need for active management of dietary supplement use by military personnel, and to develop an approach system to monitor adverse health effects. The committee was further tasked with selecting a subset of dietary supplements and, by examining published reviews of the scientific evidence, identifying those that are beneficial and/or warrant concern (see full Statement of Task in Chapter 1). The committee held a public workshop on February 12–13, 2007, in Washington, D.C., to gather results from military surveys on the use of dietary supplements, and current approaches and innovative ideas on monitoring adverse effects; this information was of primary consideration in the preparation of this report. The committee also reviewed the 2005 IOM report Dietary Supplements: A Framework for Evaluating Safety as a starting point for its deliberations. The 2005 IOM report framework was prepared to assist the FDA in evaluating scientific information to determine the level of concern prompted by use of a given dietary supplement.
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Use of Dietary Supplements by Military Personnel In developing its approach, the committee considered the special demands facing military subpopulations that set them apart from the general population. The committee further recognized that the military is able to make policy decisions (e.g., prohibit the use of a dietary supplement) based on criteria related to the needs of military subpopulations and the demands of their missions. Although the development of a detailed process to establish a dietary supplement’s level of efficacy was not within the scope of the current task, the committee did consider the importance of efficacy in developing policy on the use of dietary supplements in a military context. This summary presents the committee’s recommendations for an approach to management by military leadership of the use of dietary supplements and identifies general areas of research needs. Because the U.S. Army Medical Research Command has the official responsibility to make decisions regarding nutrition for all military services, many of the studies or policies refer to the U.S. Army. However, the recommended approach applies to all branches of the military. APPROACH TO MANAGE THE USE OF DIETARY SUPPLEMENTS BY MILITARY PERSONNEL The committee’s reviews of selected dietary supplements showed that use of some popular dietary supplements among military personnel might result in health and performance detriments if misused, particularly for those subpopulations facing demanding tasks. For example, Ginkgo biloba and garlic have anticoagulant effects, valerian and melatonin are sedative, and ephedrine-like substances may cause harmful cardiac effects. The use of multi-ingredient dietary supplements is of concern because of the unknown interactions among ingredients. Based on these factors, the committee concluded that a separate system to monitor and evaluate adverse effects is needed. This system will be one component of the committee’s recommended approach to managing dietary supplements in a military context, which comprises four related components: (1) improving monitoring of the use of dietary supplements by military personnel, (2) using a framework to determine the level of concern for dietary supplements in a military context, (3) implementing a system to report adverse events associated with dietary supplements, and (4) expanding education on dietary supplements. To demonstrate application of the framework recommended in the second component, the committee reviewed a number of dietary supplements (Chapter 4) and identified those that might pose concerns or be beneficial (Chapter 5, Table 5-3). In addition, the overall approach (i.e., recommendations for action) was applied to a subset of those dietary supplements in Appendix D. It was outside the committee’s task to provide a review of all dietary supplements. These monographs and case studies should be
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Use of Dietary Supplements by Military Personnel considered examples, and determination of the specific actions to take in response to a dietary supplement review should be the prerogative of military leadership. The committee considered organizational resources needed to follow its approach, including existing military infrastructure, policies, and organizational units and their responsibilities. For the approach to succeed, it is crucial that a military committee or entity (hereafter referred to as the designated oversight committee) has the responsibility for coordination and oversight of various dietary supplement activities (Recommendation 8). Creation of a new entity may not be feasible and, instead, the tasks of an existing one could be expanded to include the oversight of dietary supplement-related activities. The actual operational and data collection activities would rest with other existing military organizations, such as the U.S. Army Research Institute of Environmental Medicine, Center for Health Promotion and Preventive Medicine, or Office of the Assistant Secretary of Defense (Health Affairs). Improving Monitoring of the Use of Dietary Supplements by Military Personnel Data from these surveys on dietary supplement use are a key component of the committee’s approach, serving as a signal to apply the recommended framework and determine the level of concern. For example, increased use will serve as a signal to initiate a review. The committee reviewed questionnaire designs and results from eight surveys (conducted in groups of active duty military personnel; active duty, National Guard, and reserve military personnel; U.S. Army personnel; U.S. Army personnel deployed in Germany; U.S. Army Rangers; Special Forces members; U.S. Air Force personnel; and U.S. Army physicians). The surveys provide extensive data in some areas (e.g., demographics, frequency of use) but inadequate data in others (e.g., dose, association with beneficial or adverse outcomes). Within these limitations, the committee found a high use of dietary supplements (e.g., in one survey, 60 percent of respondents reported using at least one dietary supplement), especially vitamins and minerals, but also others. Vitamins and minerals were used by about 45 percent of service members on active duty; other popular dietary supplements were “bodybuilding” supplements (21 percent), and “weight-loss products” (18 percent) (see Appendix C). Recommendations 1, 2, and 3 are meant to improve the quantity and quality of data collected. Recommendation 1: Surveys to collect data on the use of dietary supplements need to continue. The committee recommends that the DoD continue to exploit a large, generic survey by expanding the DoD Sur-
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Use of Dietary Supplements by Military Personnel vey of Health-Related Behaviors managed by the Office of the Assistant Secretary of Defense (Health Affairs) with questions related to adverse events and beneficial outcomes as well as the use of specific dietary supplements that might be of concern. Recommendation 2: More comprehensive data collection is needed from select populations. The committee recommends that in-depth, anonymous surveys about dietary supplement use be administered at select military installations. These select sites would be chosen because their military populations (e.g., Special Forces or Rangers) would be more likely to use dietary supplements and face higher or unknown risks due to greater mission demands and harsher environments (e.g., high altitude, extreme temperature) than most military personnel. For example, the in-depth surveys should capture data during intense military operations that are similar to combat (e.g., Special Forces training or situations of deployment) when data collection will not interfere with mission completion. Recommendation 3: Data quality needs to be improved. Surveys should be designed in consultation with the proposed designated oversight committee, which could oversee many aspects of dietary supplement management including adverse event reporting, as described below. The system of surveillance needs to be comprehensive and include the collection of data as described in Box S-1. To obtain a more complete picture of use, survey data (from self-reported questionnaires and interviews) should be complemented with information from other sources, such as electronic health records and sales data from military installations. Professional expertise should be consulted extensively in the design, administration, and use of surveys. Using a Framework to Characterize Concern Level for Dietary Supplements in a Military Context The committee adapted the framework developed in the 2005 IOM report Dietary Supplement Use: A Framework for Evaluating Safety to characterize concern levels for dietary supplements in a military context. The 2005 IOM report framework (developed to assist the FDA in determining the level of concern from using a dietary supplement) is meant for the general population, although the report recognizes that some subpopulations may have special vulnerabilities. The committee’s adapted framework is intended to evaluate concerns about use of dietary supplements, specifi-
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Use of Dietary Supplements by Military Personnel BOX S-1 Improving Survey Designs The committee recommends that researchers implement the following additions and modifications to the surveys on dietary supplement use in order to improve their value: Frame appropriate questions, with unambiguous terminology (e.g., clarify terms such as antioxidant) and attending to the order of the questions. Design questions that expressly define a dietary supplement user (e.g., an individual consuming a dietary supplement at least once a week). Complement exposure data on dietary supplement ingredients with data from questions on consumption from other dietary sources (e.g., foods and beverages). Include questions that allow the analysis of associations of dietary supplement use with health and performance outcomes, whether adverse or beneficial. Collect data on various demographic characteristics. Collect data on the environment and conditions under which respondents use supplements (e.g., special operations). Include questions about sources of information used by military service members to determine the most effective methods of dissemination of information. cally considering the vulnerabilities and needs of military subpopulations (Recommendations 4, 5, and 6). For example, the criteria that categorize adverse effects differ: effects that would not be considered serious in the civilian population (e.g., drowsiness) might compromise the performance of a military service member and therefore initiate a review. Also, in contrast to the IOM framework, the review of dietary supplements and corresponding management actions attends to the specific environment, missions, and military subpopulations. Furthermore, because of the military’s emphasis on individual readiness and performance, management of dietary supplements needs to weigh the potential for risks against benefits, rather than predicate action solely on risk. The general steps in the adapted framework—signal detection, initial review of signals, and integrated safety evaluation—are depicted in Figure S-1. The committee recognizes three challenges in applying its framework to determine level of concern: insufficient data on safety and efficacy, dietary supplements that contain multiple ingredients, and the presence of contaminants (Box S-2). When addressing these challenges, the military might need to apply temporary policies until a definitive conclusion is reached.
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Use of Dietary Supplements by Military Personnel FIGURE S-1 Framework to review the safety of dietary supplements aHigh physical activity, calorie restriction, hydration, gastrointestinal tract (diarrhea/nausea), liver health/function (xenobiotic clearance), cardiovascular health, mood/behavior altering, alertness/drowsiness, extreme heat/cold, injury/bleeding.
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Use of Dietary Supplements by Military Personnel BOX S-2 Potential Challenges When Applying the Recommended Framework Insufficient scientific data. Acquisition of sufficient scientific data from literature searches to support an informed decision about the safety and efficacy of a dietary supplement within the military will be a challenge. The committee emphasizes that absence of evidence of risk, a frequent reality, does not necessarily indicate that there is no risk, but might reflect inadequacy of the study design to identify risk. In areas of notable concern where significant data gaps exist, the military should perform research as recommended below. Multi-ingredient dietary supplements. Dietary supplements commonly contain multiple ingredients, which are often reformulated with different ratios, amounts, and even constituents. Finding data on the safety of the multi-ingredient products in the market is a yet greater challenge than finding data for single-ingredient products. There are two potential approaches to determining the safety or efficacy of these products; both offer pros and cons. In one approach, the military could conduct research on the composite dietary supplement product using military subpopulations under performance environments of interest. This approach would more accurately reflect usage, but would be costly, time-consuming, and given the rapid turnover of products in the market, impractical. Another approach would be to review the safety of each individual ingredient. Here, limitations are twofold and relate not only to the possible dearth of data for the effects of the ingredients themselves, but for the interactions among ingredients. The committee concluded that these products merit special consideration and should be frequently monitored for use, sales, and adverse event reports. Presence of contaminants. The linking of an adverse event to the use of a dietary supplement ingredient might be confounded if the product contains adulterants or contaminants. If contamination occurs, then attribution of the source of the adverse event becomes a formidable task. If enforced, the newly adopted current Good Manufacturing Practices (cGMPs) rule should minimize the potential for inclusion of adulterants or contaminants. Recommendation 4: The decision to initiate a review of a dietary supplement should be based on two criteria: severity and number of adverse events, and prevalence of use. The selection of dietary supplements for review should consider the particular vulnerabilities of the military subpopulation, which would depend on their missions and mission environments. Summaries of adverse events reported in military and nonmilitary settings and data on use will be evaluated by the designated oversight commit-
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Use of Dietary Supplements by Military Personnel tee, which will provide guidance to military leadership about the need to review a dietary supplement. For example, if the surveys indicate frequent use, or if adverse events reported are of moderate concern, use of the framework by a review panel to evaluate published science-based safety reviews might be recommended. If summaries indicate serious adverse events, generating a high risk of concern, then a more immediate action might also be recommended (e.g., restriction of use) (Figure S-1). The committee recommended that the evidence (e.g., how many adverse events were associated with the dietary supplements, how strong the association, level of intake, intake of other medications/supplements, actual circumstances, characteristics of the individual) for an adverse event be reviewed and that the level of concern be determined by taking into consideration not only the the strength of the evidence but also the tasks of the specific military subpopulation and the environment in which these tasks will be conducted. Recommendation 5: The military should use the framework (Figure S-1) to review the dietary supplements that raise safety concerns (per criteria above). The framework consists of the integrated evaluation of results from current, authoritative reviews (or, if no reviews are available, original research conducted over the previous 10 years) analyzing bioactivity and potential for drug interactions. When evaluating the safety of a dietary supplement, the military should follow the criteria on which to determine the level of concern (i.e., high, moderate, low, and minimal) and the principles in the 2005 IOM report, but with heightened attention to optimal performance and to the risks to survivability of military service members under the environmental conditions and demands of military operations. For example, if a product significantly contributes to hypoxia, its use may be of high concern for aviators (see Chapter 1, Box 1-3). A review panel that includes nutritionists, epidemiologists, toxicologists, clinicians, and pharmacognosists should conduct the reviews and determine the level of concern. Recommendation 6: The military’s decisions on dietary supplement policy (e.g., rules, education, monitoring of use) should be based on conclusions about both safety and efficacy derived from the available published, authoritative scientific literature and considering conditions associated with a specific type of mission, location, and environment. Determining the specific actions to take in response to a dietary supplement review should be the prerogative of military leadership. In some cases, the policies may apply to all services and therefore be established by DoD Health Affairs; in other cases, policies may be established by each service
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Use of Dietary Supplements by Military Personnel or by individual commanders who are knowledgeable about the tasks and circumstances of a particular military subpopulation. Policy decisions based on scientific reviews should use a model similar to the risk analysis model. Determinations about the level of concern and benefit should be made by a review panel (parallel to the “risk assessment” concept in a risk analysis model), whereas the decisions about implementing military policy should be made by military leadership (e.g., DoD Health Affairs in consultation with the designated oversight committee, which has an advisory role; or military commanders in consultation with the local Medical Treatment Facilities’ Pharmacy and Therapeutics [P&T] Committees and the designated oversight committee), paralleling the “risk management” concept in a risk analysis model. This model can be useful in making policy only when scientists work in consultation with military leadership, so that technical questions arising from reviews or other data and questions on the circumstances of military subpopulations can be clarified. Implementing an Adverse Event Surveillance System The military lacks a systematic process by which adverse events linked to dietary supplement use are reported, analyzed, and used as the basis for making management decisions. Implementing such a system is justified, especially considering the dangerous tasks and extreme environments faced by some military populations. This system, the third component of the committee’s approach, will serve as a signal to initiate a review of a dietary supplement or implement policy (e.g., restrict the use of a dietary supplement). Recommendations are provided in three areas: (1) the implementation of an adverse event reporting system for military personnel (Recommendations 7, 8, and 9), (2) the establishment of a forum or coalition to share data and information related to dietary supplements (Recommendation 10), and (3) increasing the reporting of adverse events by broadening outreach activities and educational programs (Recommendations 11 and 12). To the extent possible, the adverse event reporting system currently in use for medications could be expanded to include dietary supplements. Recommendation 7: The military should use a centralized monitoring system for reporting dietary supplement adverse events (and data on use), in which data are recorded through the integrated electronic health record system already being implemented in the military. The DoD should ensure that future electronic health records adequately capture dietary supplement use and adverse event data by soliciting this information during medical visits. For instance, it would be appropriate
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Use of Dietary Supplements by Military Personnel during medical visits to add a standard assessment question(s) as part of the routine office check-in. In addition, future electronic health records should be capable of generating standard reports on frequency of use and adverse event data that can be aggregated for analysis; and automated alerts to signal a significant change in usage or adverse event reporting, or to signal a risk of interaction with a medication or other treatment. Recommendation 8: The military should designate a committee or military entity to be responsible for the oversight and coordination of dietary supplement-related activities, such as overseeing the adverse event surveillance system and parallel educational components. This designated committee will have an advisory role; it should provide input to the DoD leadership on military policies in matters addressing the safety and efficacy of dietary supplements. These include recommendations on when to initiate a safety review, where to focus research, and the design of educational programs and materials for military service members as well as for health care professionals that highlight the benefits and risks of dietary supplement use. The committee should do the following: Advise the DoD on the mechanisms for submission of adverse event reports and a process for provision of summaries to those with leadership or educational roles. Identify relevant databases and efforts related to surveillance of adverse events associated with dietary supplement use by military and nonmilitary groups. Participate in a coalition or forum to exchange and share data and information related to dietary supplements (Box S-3). Recommendation 9: The responsibilities of the local Medical Treatment Facilities’ Pharmacy and Therapeutics Committees should be extended to reviewing and summarizing the adverse event reports as submitted by health care providers or service members, and preparing and providing summaries via a process recommended by the designated oversight committee. To conduct these tasks, P&T Committees should not only have appropriate scientific expertise, but should be familiar with the demands and conditions unique to military operations and be experienced in identifying serious or unexpected adverse effects, especially when relevant to military performance.
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Use of Dietary Supplements by Military Personnel BOX S-3 Suggested Partners of a Forum or Coalition to Share Data on Dietary Supplements Designated military committee to oversee dietary supplements Registered dietitians from U.S. Air Force, U.S. Army, and U.S. Navy (DoD Nutrition Committee) U.S. Army Research Institute of Environmental Medicine Pharmacist from DoD Pharmacoeconomic Center, U.S. Air Force, U.S. Army, and U.S. Navy Medical representative from U.S. Air Force, U.S. Army, and U.S Navy FDA’s Center for Food Safety and Applied Nutrition Federal Trade Commission NIH’s Office of Dietary Supplements Army and Air Force Exchange Service, Navy Exchange Service Supplement sales outlets located on military installations Industry trade associations Health and Wellness and Health Promotion Centers from U.S. Air Force, U.S. Army, and U.S. Navy Fitness centers or unit trainers from U.S. Air Force, U.S. Army, and U.S. Navy Optional additional representatives Sharing Data and Information Recommendation 10: The committee recommends that a coalition or forum be established for the exchange of data and information related to dietary supplements, such as data from surveillance of dietary supplement use and adverse events. The members of this forum (military and nonmilitary government organizations, nongovernmental organizations, and industry) would share data on adverse event summaries and reports as well as educational and outreach materials and activities. Members would also share data related to sales and use of dietary supplements and associated adverse events (or beneficial effects) in the military and civilian populations. Participants of the forum should include, among others, experts in toxicology and safety evaluation of natural products. Expanding Education: Training and Outreach The committee recognizes the importance of expanding educational programs and outreach activities to increase awareness about the effects of
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Use of Dietary Supplements by Military Personnel dietary supplements. These educational elements are key to supporting an effective, centralized adverse event monitoring system. Recommendation 11: Military service members and commanders should be educated to recognize both the potential adverse effects and benefits from using specific dietary supplements and the importance (and the process) of reporting an adverse event. The designated oversight committee should oversee the development of and recommend educational materials to be disseminated for this purpose (e.g., point-of-sale brochures, posters, or websites). Recommendation 12: Health care personnel should be trained in evaluating dietary supplement use, informing and obtaining information from their patients, and appropriately reporting adverse events. Education should be included in existing programs (e.g., Uniformed Services University of Health Sciences, internships and residencies, aerospace medicine training, independent duty medical technician training, and mandatory continuing education at medical staff meetings). RESEARCH NEEDS The committee was requested to select a limited number of dietary supplements to review and then determine whether further examination and integrative evaluation or research on each is warranted. Consequently, the committee did not attempt to provide an exhaustive listing of research needs and instead, presents key considerations for conducting dietary supplement research in a military context and an approach to prioritize research needs according to the special needs of military subpopulations. Key Considerations for Conducting Military Nutrition Research Study Designs Studies to investigate the safety and efficacy of dietary supplements in a military context should be performed using the existing military human models that mimic the physical stresses and environments that accompany military missions and training programs (e.g., a predefined course). The selection of subjects should take into consideration physiological differences and reflect demographic factors of the military population that might result in different effects of dietary supplement use. Research populations should particularly represent those participating in garrison training, serving in combat, or both and should be selected according to
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Use of Dietary Supplements by Military Personnel a well-designed research plan that permits generalizations to the target populations. Access to analytical capabilities is a vital element of those studies designed to assess the identity and integrity of dietary supplement products associated with reported adverse events, possibly by contracting with appropriate research facilities. Animal Models Human models that simulate severe mental and emotional stresses and some toxicological tests present practical and ethical limitations. The military should continue the development of animal model systems that mimic the stresses of military personnel, particularly those facing demanding tasks and environments such as those in garrison training and combat, to allow screening for physiological effects of dietary supplements used under extreme conditions. Screening with well-designed and ethical animal studies could be followed with more focused human studies, possibly in collaboration with civilian researchers. Approaches to Identifying Research Needs Future studies on dietary supplement use in the military should be approached from an etiological or mechanistic perspective. To prioritize research needs, the military should include input from all the services. The designated oversight committee should be tasked with providing recommendations to the DoD on research to be pursued or funded. Gaps in data should be identified based on the following elements of the recommended approach: (1) results of the surveillance system on the use of dietary supplements, (2) gaps identified in the reviews conducted for specific dietary supplements, and (3) occurrence of adverse events of military importance associated with the use of specific dietary supplements. In addition, research conducted in the civilian population should be monitored for potential military implications. Following a similar approach, the committee provides a list of potential, general research topics and activities in Box S-4; however, as mentioned above, to increase the value of this exercise, the identification of research gaps should include coordinated input from all military services. Safety The military should develop a list of adverse effects of particular concern (see Box 5-1 in Chapter 5). The military might generate requests for
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Use of Dietary Supplements by Military Personnel BOX S-4 Potential Research Topics and Activities Continue to gather data on ration nutrient composition and total dietary intake of vitamins and minerals by military personnel Consider establishing Tolerable Upper Intake Levels (ULs) for the military in special conditions (e.g., during combat when the risk of injury is high, the intake of vitamin E [or other compounds with thrombolytic potential] might need to be restricted); follow the ULs for the general population and include them in Military Dietary Reference Intakes Continue collecting and analyzing data on dietary supplement use Monitor the frequency and severity of adverse events associated with popular or potentially beneficial dietary supplements Develop methodologies to assess safety (and efficacy) of multi-ingredient dietary supplements Study the effects of interactions with other supplements, foods, or medications Consider study designs that allow for identification of tolerance and withdrawal effects associated with popular or potentially beneficial dietary supplements Validate the recommended approach to manage dietary supplements Evaluate the efficacy of education methods Investigate the potential beneficial effects of dietary supplements to mitigate or recover from stress Explore the use of dietary supplements for the prevention or treatment of injuries (e.g., wound healing, traumatic brain injury, or post-traumatic stress disorder) proposals for methods to evaluate safety in these areas, or of any classes of compounds that could be expected to cause such safety issues. Benefit The committee recommends that the military identify physical and mental performance areas where improvement is of interest. In addition, the military should consider a future study to develop a framework approach to determine whether a dietary supplement is efficacious. Concomitantly, the military could take an approach similar to that suggested for safety, that is, to issue requests for proposals that cover both methods for evaluation and the particular class of compound that might be expected to confer these benefits. Studies on beneficial effects should be designed so that adverse effects can be identified.
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