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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

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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