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Vitamin D and Health

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

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