Vitamin D supplementation does not improve CVD risk factors in vitamin D-insufficient subjects
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Interventional (Human) Studies
81
Enhanced Details
Methods
Double-blind randomized controlled trial in adults with vitamin D insufficiency recruited from the Tromsø region in Northern Norway. The study randomized 422 participants in a 1:1 ratio; 211 were assigned to vitamin D and 211 to placebo, with the vitamin D arm reporting 208 completers. Baseline cohort characteristics included a mean age of 50 years, BMI of 28 kg/m^2, and mean serum 25(OH)D of 34 nmol/L.
Intervention
Participants in the active arm received oral cholecalciferol capsules: a 100,000 IU loading dose (five 20,000 IU capsules), followed by 20,000 IU per week for 4 months. The comparator was identical placebo capsules containing arachis oil.
Results
Vitamin D supplementation did not improve cardiovascular risk factors in vitamin D-insufficient adults. Serum 25(OH)D rose by 56 nmol/L in the vitamin D group and fell by 4 nmol/L in the placebo group, but there were no statistically significant between-group differences in blood pressure, lipids, or glucose metabolism measures. A minor increase in sRAGE was observed, including a significant delta value in the specified subgroup (P < 0.05), but subgroup analyses did not show overall benefit. No serious study-related side effects were reported, although two participants developed hypercalcemia.
Limitations
The intervention lasted only 4 months, which may be too short to detect changes in cardiovascular outcomes. Generalizability is limited to vitamin D-insufficient adults from one northern Norwegian region, and arm-specific ethnicity, diet, and physical activity data were not reported. The trial also yielded no supportive benefit in subgroup analyses, despite clear biochemical repletion.
Abstract
Objective Low serum 25(OH)D levels are associated with cardiovascular disease (CVD) and some of its risk factors. However, in interventional studies, the effects of vitamin D supplementation have been uncertain, possibly due to inclusion of vitamin D...