A Randomized Trial of Vitamin D Supplementation on Vascular Function in CKD.
What this study found
Cholecalciferol improved endothelial function and arterial stiffness over 16 weeks in vitamin D-deficient, non-diabetic CKD patients. Flow-mediated dilation increased by 5.42% within the cholecalciferol arm, with a between-group mean change difference of 5.49% versus placebo, and pulse wave velocity decreased significantly. Serum 25(OH)D rose by 24.91 ng/mL, while inflammatory and mineral metabolism markers also improved, including significant reductions in IL-6 and parathyroid hormone. The intervention was well tolerated, with no hospitalizations, no serious adverse events, and no severe…
- Study & population
- Randomized, 1:1 placebo-controlled trial in adults 18 to 70 years old with non-diabetic chronic kidney disease stage 3 to 4 and vitamin D deficiency, conducted at PGIMER in Chandigarh, India.
- Intervention
- Cholecalciferol (native vitamin D) was given orally as 300,000 IU under direct observation at baseline and again 8 weeks later, for a 16-week follow-up.
- Key limitation
- The trial was relatively small, single-center, and short term, with only 16 weeks of follow-up.
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Open PDFOriginal abstract
Vitamin D deficiency associates with mortality in patients with CKD, and vitamin D supplementation might mitigate cardiovascular disease risk in CKD. In this randomized, double-blind, placebo-controlled trial, we investigated the effect of cholecalciferol supplementation on vascular function in 120 patients of either sex, aged 18-70 years, with nondiabetic CKD stage 3-4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml). We randomized patients using a 1:1 ratio to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in endothelium-dependent brachial artery flow-mediated dilation at 16 weeks. Secondary outcome measures included changes in pulse wave velocity and circulating biomarkers. Cholecalciferol supplementation significantly increased endothelium-dependent brachial artery flow-mediated dilation at 16 weeks, whereas placebo did not (between-group difference in mean change: 5.49%; 95% confidence interval, 4.34% to 6.64%; P<0.001). Intervention also led to significant favorable changes in pulse wave velocity and circulating IL-6 levels. Thus, in nondiabetic patients with stage 3-4 CKD and vitamin D deficiency, vitamin D supplementation may improve vascular function. This study is registered with the Clinical Trials Registry of India (no.: CTRI/2013/05/003648).