Vitamin D and Health
SACN_Vitamin_D_and_Health_report
SACN_Vitamin_D_and_Health_report
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Study Methods Results Author’s conclusions<br />
Bischoff-Ferrari et<br />
al (2009)<br />
Selection criteria<br />
Inclusion: Oral vitamin D supplementation (D2<br />
or D3); minimum follow-up 1y; > 1 fracture;<br />
mean age ≥ 65 y; double-blinded; adherence<br />
reported; explanation of how fractures<br />
ascertained.<br />
Exclusion: Uncontrolled trials; observational<br />
studies, animal studies; studies with patients<br />
following organ transplantation or stroke,<br />
receiving steroid therapy or with Parkinson’s<br />
disease or unstable health states.<br />
Outcome measure<br />
Nonvertebral or hip fracture.<br />
12 double-blind RCTs (n=42,279) comparing oral vitamin D (± Ca) with calcium or placebo.<br />
Nonvertebral fractures (12 RCTs): RR = 0.86 (0.77-0.96)<br />
Evidence of heterogeneity (Q test: p=0.04); resolved after stratifying trials by received dose<br />
For 3 trials ≤ 10 µg, RR = 1.02 (0.92-1.15) (Q test, p=0.64)<br />
For 9 trials ≥ 10 µg, RR = 0.80 (0.72-0.89) (Q test, p=0.31)<br />
Hip fractures (8 RCTs): RR = 0.91 (0.78-1.05)<br />
Evidence of heterogeneity (Q test, p=0.08); resolved after stratifying trials by received dose<br />
For 3 trials ≤ 10 µg, RR = 1.09 (0.90-1.32) (Q test, p=0.81)<br />
For 5 trials ≥ 10 µg, RR = 0.82 (0.69-0.97) (Q test, p=0.18)<br />
Non-vertebral fracture prevention<br />
with vitamin D is dose dependent.<br />
A higher received dose of<br />
supplemental vitamin D (12-19 µg<br />
daily) should reduce nonvertebral<br />
fractures by at least 20% <strong>and</strong> hip<br />
fractures by at least 18%.<br />
Table 23: RCTs on vitamin D supplementation <strong>and</strong> increased fracture risk in adults ≥ 50y<br />
Study/country Population Intervention & duration Baseline 25(OH)D<br />
concentration (nmol/L)<br />
12 m post intervention 25(OH)D<br />
concentration (nmol/L)<br />
Results<br />
Comments<br />
S<strong>and</strong>ers et al<br />
(2010)<br />
Victoria,<br />
Australia<br />
Women considered<br />
to be at high risk of<br />
fracture (n=2256)<br />
Age: 70+ y.<br />
1. 12,500 µg D3 given as<br />
single annual dose orally.<br />
2. Placebo<br />
Duration: 3-5 years<br />
(n=131)<br />
Median (IQR): 49 (40-63)<br />
≥ 74<br />
1. 9.5%<br />
2. 5.3%<br />
51-74<br />
1. 44.5%<br />
2. 33.32%<br />
26-50<br />
1. 41.9%<br />
2. 57.9%<br />
≤ 25<br />
1. 4%<br />
2. 3.5%<br />
<strong>Vitamin</strong> D vs placebo group:<br />
Incident rate ratio:<br />
1.26 (95% CI, 1.00-1.59)<br />
(p=0.047)<br />
Significant increase in<br />
fracture with high dose of<br />
vitamin D3.<br />
201