Table 7.
Summary of interventional studies evaluating the effect of vitamin D supplements on chronic kidney disease (CKD) risk
| Source | Study design | Objective | Population (cases) | Main outcome(s) |
|---|---|---|---|---|
| Alvarez et al122 | Randomized, double-blind, placebo-controlled trial | To investigate the effect and safety of high-dose cholecalciferol (50,000 IU/week for 12 weeks followed by 50,000 IU every other week for 40 weeks) on serum parathyroid hormone (PTH) in CKD patients | 46 subjects with early CKD (stage 2–3) | After 1 year, this oral cholecalciferol regimen was safe and sufficient to maintain serum 25(OH)D3 concentrations (≥30 ng/mL) and prevent vitamin D insufficiency in early CKD; furthermore, serum PTH improved after cholecalciferol treatment |
| Alvarez et al123 | Randomized, double-blind, placebo-controlled trial | To investigate the effect and safety of high-dose cholecalciferol (50,000 IU/week for 12 weeks followed by 50,000 IU every other week for 40 weeks) on circulating markers of inflammation in CKD patients | 46 subjects with early CKD (stage 2–3) | High-dose cholecalciferol decreased serum MCP-1 concentrations by 12 weeks in patients with early CKD |
| Shroff R et al127 | Randomized, placebo-controlled, double-blind study | To investigate the effect of ergocalciferol supplementation on the onset of secondary hyperparathyroidism in children with CKD stage 2–4 | 72 children with CKD (stage 2–4) | Ergocalciferol is an effective treatment that was effective in increasing 25(OH)D3 and decreasing PTH levels in patients with moderate chronic kidney disease |
| Kooienga et al125 | Randomized, placebo-controlled, double-blind study | To investigate the effects of vitamin D3 supplementation on secondary hyperparathyroidism in patients with moderate CKD | 639 elderly women (moderate CKD) | Vitamin D3 was effective in increasing 25(OH)D3 and decreasing PTH levels in patients with moderate CKD |
| Chandra et al124 | Randomized, placebo-controlled, pilot study | To investigate the effect and safety of high-dose cholecalciferol (50,000 IU/week for 12 weeks) in CKD patients | 34 subjects with CKD (stages 3 and 4) | Weekly cholecalciferol supplementation appeared to be an effective treatment to correct vitamin D status and PTH in CKD |
| Marckmann et al126 | Randomized, placebo-controlled, double-blind study | To investigate the effect and safety of cholecalciferol (40,000 IU/week for 8 weeks) in hemodialysis (HD) and non-HD CKD patients | 52 subjects with CKD (stages 3 and 4) | This oral cholecalciferol regimen was safe, and had favorable effects on 1,25(OH)2D3 and PTH in non-HD patients |
| Molina et al120 | Randomized, placebo-controlled, double-blind study | To investigate the effect of vitamin D (666 IU/day for 6 months) on albuminuria in proteinuric CKD patients | 101 nondialysis CKD patients with albuminuria | Vitamin D supplementation with daily cholecalciferol had a beneficial effect in decreasing albuminuria, with potential effects on delaying the progression of CKD |
| Moe et al170 | Randomized, double-blind study | To investigate the effect and safety of cholecalciferol (4,000 IU/day ×1 month, then 2,000 IU/day ×2 months) or doxercalciferol (1 μg/day ×3 months) in CKD patients | 47 subjects with CKD (stages 3 and 4) | Both cholecalciferol and doxercalciferol decreased PTH; there was no significant difference between groups |
| Stubbs et al128 | Uncontrolled study | To investigate whether 25(OH)D repletion affects vitamin D-responsive monocyte pathways in vivo | 7 patients with HD | Vitamin D therapy had a biologic effect on circulating monocytes and associated inflammatory markers in end-stage renal disease patients |
| Albalate et al130 | Randomized, double-blind study | To investigate drug or dosing regiments in CKD patients | 217 HD patients | In HD patients, calcifediol increased 25(OH)D3, serum calcium, and phosphates and lowered PTH |
Abbreviation: HD, hemodialysis.