Trial registrationĬ identifier: NCT01170494 (registered July 25, 2010). D2 may be 25-hydroxylated faster than D3. D2-associated reduction in 25(OH)D3 level may be related to total 25(OH)D level rather than being D2-specific. ConclusionsĮffects of D2 and D3 supplements on 25 (OH)D level may be dosing-schedule and sex-dependent. Baseline 25(OH)D level predicted response to D2 and D3 ( p < 0.001), whereas, BMI was significant predictor only for early response to D2. Incremental AUC 7 of D3 and 25(OH)D3 in D3-treated groups and D2 and 25(OH)D2 in D2-treated groups were higher in females than males (55, 13, 64, and 28%, respectively). Incremental AUC from day 0 to 7 (AUC 7) of D3 and 25(OH)D3 in D3-treated groups were 118–243% higher and 31–39% lower, respectively, than incremental AUC 7 of D2 and 25(OH)D2 in D2-treated groups. In D2-treated groups, there was 16.4 nmol/L decrease in 25(OH)D3 level that correlated ( p < 0.001) with 25(OH)D2 level increase ( r = 0.48) and baseline 25(OH)D level ( r = 0.58), in one participant with measurable baseline 25(OH)D2 level, D3 caused a similar decrease in 25(OH)D2 level, while in the D2/D3-treated group, 25(OH)D3 level didn’t increase.
AUC from day 0 to 140 (AUC 140) of 25(OH)D was 40% (D3 daily) to 55% (D3 2-weekly) higher with active-treatment than placebo ( p < 0.001). Baseline 25(OH)D level was 39.8(11.9) and increased by 3.3(11.6) and 28.6(16.3) nmol/L, in the placebo and active-treatment groups, respectively. Mean(SD) age was 33.0(8.5) year, 41% were males, and 85% completed follow-up. Primary endpoint was area-under-the-curve (AUC) of 25(OH)D (25(OH)D2 + 25(OH)D3) adjusted for sex, BMI, and baseline 25(OH)D level.
The results of 269 participants were available for analysis. D2, D3, 25(OH)D2, and 25(OH)D3 Serum levels were determined blindly on days 0,1,2,3,4,7,14, and 2-weekly thereafter by high performance liquid chromatography assay.
Randomization sequence, stratified by body-mass-index (BMI) and sex, was concealed from study coordinators and participants who were then blinded to capsules’ content.
We randomized 279 adults to daily D2, D3, D2/D3, or placebo 2-weekly D2 or D3 or 4-weekly D2 or D3 (250,000 IU over/140 days). Controversy continues on ergocalciferol (D2) and cholecalciferol (D3) relative potency as well as on dosing-schedule and sex role in raising 25-hydroxy D (25(OH)D) level, the best indicator of D status. Vitamin D (D) supplements are indispensable for its world-wide deficiency.
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