|
Author (year)
Duration
(Timepoints for Toxicity Assessment)
|
% Vitamin D Deficient
Population
Exclusion Criteria
Ethnicity (country)
|
Sample Size
|
Intervention
Compliance
|
Followup Serum 25(OH)D (nmol/L)
Assay
|
Safety Outcomes
|
|
Lips (1988)209
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79 % (serum 25(OH)D <30 nmol/L)
35% < 20 nmol/L
|
IG1: 70
IG2: 72
|
IG1: 400 IU vit D3/d
IG2: 800 IU vit D3/d
|
increased to > 40 nmol/L in all subjects (means (SD) presented in graph only)
|
Hypercalcemia:
IG1: 0
IG2: 1 (associated with thiazide use)
|
|
1 year
|
|
|
(2, 3 and every 3 mo thereafter)
|
Men and women living in two different levels of institutional care; mean age (SD): 81 (9) y nursing home); 84 (6) y (senior home)
|
Completers:
nursing home:
50/72 (69%)
seniors home:
59/70 (84%)
|
|
Ca/Cr ratio:
fasting urinary Ca excretion increased ~ 15% unrelated to treatment in all groups, NS serum Cr: increase of ~ 4% in all groups (significant increase from baseline)
|
|
|
Compliance NR
|
|
|
|
|
Excluded subjects with hypercalcemia, active urolithiasis, or chronic renal failure
|
|
|
CPBA
|
Mortality:
IG1: 223/1291 (17.2%)
CG: 251/1287 (19.5%)
|
|
|
NR (The Netherlands)
|
|
|
|
|
|
Mastaglia (2006)212
|
NR median 36.25 (range 27.5-48.12)
|
IG1 13
IG2 13
CG 12
|
IG1: D2 5,000 IU/d + Ca 500 mg
IG2: D2 10,000 IU/d + Ca 500 mg
CG: Ca 500 mg
|
25(OH)D median (25-75th percentile):
|
Hypercalcemia:
IG1: 0;
IG2: 0 (increase in mean serum Ca at 2 mo but WNL)
CG: 0
|
|
3 mo
|
Post menopausal
osteopenic/osteoporotic women aged 50 - 70 y presenting for bone mass evaluation
|
|
|
|
|
|
IG1 77.5 (66.2-156.2)
IG2 97.7 (79.3-123.1)
CG: 55.0 (72.5-68.0)
|
|
(0, 1, 2 and 3 mo)
|
|
|
|
|
|
|
|
|
Hypercalciuria:
IG1: 1 (urinary Ca excretion increased from 99.0 (69.5-147.5) to 152 (102-204) mg/24 h, p<0.05, at 3 mo);
IG2: 1 (urinary calcium excretion increased from 121 (88.7-140) mg/24h to 149 (120.7-225.7) mg/24h, p<0.05, at 3 mo);
CG: 1 (urinary Ca excretion not increased)
|
|
|
|
|
Compliance (pill and drop counts):
89 (11)-92 (10)%
|
|
|
Excluded subjects treated with vitamin D or drugs known to affect bone or vitamin D metabolism
|
|
|
|
|
|
RIA (Diasorin)
|
|
|
NR (Argentina)
|
|
|
|
|
|
|
|
|
|
|
no urinary Ca/Cr ratio >0.37mg/dL
|
|
oral route of administration unless otherwise specified; 2 measured at 2 wks and 6 mo post dose; 3 measured at 2 wks post 1st and 2nd dose, and 3 mo after each of the three doses
Ca, calcium; CG, control group; CPBA, competitive protein binding assay; Cr, creatinine; d, day; D, vitamin D, isoform not specified in publication; dL, deciliter; GI, gastrointestinal; HRT, hormonal replacement therapy; IG, intervention group; IQR, interquartile range; IU, international units: mo, month(s); mg, milligram; mo, month(S); ND, not done: NR, not reported; RIA, radioimmunoassay; WNL, within normal limits;
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