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the usual diet consumed in the United States is 15 μg/1,000 kcal (Anderson and Kozlovsky, 1985).

Picolinic acid, as an endogenous metabolite of tryptophan metabolism, is present in human tissues only in trace amounts (Rebello et al., 1982). Some picolinic acid is expected to be present in the diet in small amounts; however, this subject has not been studied extensively.

Chromium picolinate is widely included in dietary supplements, especially in multivitamin, multimineral products. These supplements are usually available in capsule or tablet form.

Typical amounts of chromium picolinate used in multivitamin, multimineral dietary supplements range from 50 to 400 μg/day. Specialty dietary supplements may contain much more chromium picolinate and may include other forms of both chromium and picolinate. Chromium picolinate is also readily available in single-ingredient preparations or in combination with a few ingredients.

A. Summary

This monograph summary considers the safety of chromium picolinate as well as Cr(III) and picolinic acid to the degree to which they are expected to impact the safety of chromium picolinate.

The human data regarding chromium picolinate safety was derived from 17 randomized, double-blind, placebo-controlled human clinical trials of oral chromium picolinate; 2 similar trials (confounded by the choice of subjects with gestational diabetes or publication in German); 3 cross-over-design trials; 1 uncontrolled study in subjects with diabetes; 1 phase II study; 2 pilot studies; 1 questionnaire; 11 clinical case reports; 1 case series report; and 21 spontaneous adverse event reports to Special Nutrition/ Adverse Event Monitoring System where chromium picolinate was the lone supplement reported. Data were also examined from adverse event reports in which two or more supplements containing chromium picolinate were ingested; all of these reports involved serious adverse events.

Animal and in vitro general toxicity data, as well as data addressing the questions raised by human data, were collected using literature searches. The quality and quantity of the data from in vitro, animal, and human experiments and studies is good and also reasonable. The benchmark for this conclusion is the quality and quantity of data for nutritional supplements in general. Data from questionable sources outside the widely accepted medical literature were included in footnotes to the data tables in the full monograph to indicate awareness of this data; however, little value was placed on this type of data.

No consistent, frequent adverse events were evident from the human data, although most of the human studies were not informative with regard



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