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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

Kenny (2003)113

NR

IG1: 33

CG: 32

IG1: I,000 IU/d vit D3 + 500 mg Ca/d

CG: Placebo + 500 mg Ca/d

baseline mean (SD)

IG1: 65 (17.5)

CG: 60 (17.5)

6 mo followup: significant increase in IG1 but not CG (graph)

Hypercalcemia: 0 hypercalciuria: 0

No AE identified

11 weeks

men ≥ age 65 years

 

 

 

 

92% completers

Urinary Ca (mg)/Cr (g) increased similarly in both groups.

IG1: baseline 96 (65) and 6 mo 134 (89)

CG: baseline 95 (80) and 6 mo 129 (101)

(baseline, 3 and 6 mo)

excluded those with systemic disease or unresolved endocrine disorder known to affect muscle metabolism; use of androgens, estrogens, or dehydroepiandosterone (previous 12 months), use of cholecalciferol (previous 4 wks).

 

 

 

 

87.3 (13.8)

WDAE: 0

 

 

 

 

CPBA

 

 

NR (U.S.)

 

 

 

 

Krieg (1999)207

NR

IG1: 124

CG: 124

IG1: 440 IU D3 + 1,000 mg Ca carbonate/d (Ca in 2 doses)

CG: No treatment

mean (SEM):

baseline

IG1: 29.8 (3)

CG: 29.3 (3)

1 y

IG1: 74.5 (2.3)

CG: 20.8 (2.8)

2 y

IG1: 66.3 (4)

CG: 14.3 (2.5)

Mean serum Ca (SEM):

IG1: 2.31 (0.02)

CG: 2.23 (0.01)

2 years

Elderly institutionalized women

 

 

 

completers:

IG: 50 (40.3%)

CG: 53 (42.7%)

 

 

NR

 

Hypercalcemia:

IG1: 1 (withdrew)

CG: 0

 

 

 

 

NR (Switzerland)

 

compliance NR

 

 

 

 

 

GI:

IG1: 6 subjects (5%) with upper GI side effects withdrew

CG: 0 withdrew due to upper GI symptoms

 

 

 

 

CPBA

 

 

 

 

 

Mortality:

IG1: 21/124 (16.9%)

CG: 26/126 (20.6%)



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