Hyperparathyroidism resulting from CKD eliminated by 8,000 IU of vitamin D daily for 12 weeks– RCT 2018

High doses of cholecalciferol alleviate the progression of hyperparathyroidism in patients with CKD Stages 3–4: results of a 12-week double-blind, randomized, controlled study

Nephrol Dial Transplant (2018) 33: 466–471 doi: 10.1093/ndt/gfx059
Per-Anton Westerberg1,2, Gunnar Sterner3, Osten Ljunggren € 1, Elin Isaksson3, Fjo¨lnir Elvarson1,
Hamid Dezfoolian4 and Torbjo¨rn Linde1


Background. Calcidiol insufficiency may accelerate the development of secondary hyperparathyroidism (SHPT). We
tested the effect of a substantial increase in calcidiol on mineral metabolism in patients with chronic kidney disease (CKD).

Methods. Ninety-five patients with CKD Stages 3–4, parathyroid hormone (PTH) above 6.8 pmol/L and calcidiol below 75 nmol/L were randomized to receive either cholecalciferol 8000 IU/day or placebo for 12 weeks. The primary endpoint was difference in the mean change in iPTH after 12 weeks. The proportion of participants having a 30% reduction in PTH and the effect on hand grip strength, fatigue and different biochemical variables were also investigated.

Results. Baseline calcidiol was 57.5 6 22 and 56.8 6 22 nmol/L in the cholecalciferol and placebo groups, respectively. The corresponding concentrations of PTH were 10.9 6 5 and 13.1 6 9 pmol/L. Calcidiol increased to 162 6 49 nmol/L in patients receiving cholecalciferol, and PTH levels remained constant at 10.5 6 5 pmol/L. In the placebo group, calcidiol remained stable and PTH increased to 15.2 6 11 pmol/L. The mean change in PTH differed significantly between the two groups (P < 0.01). The proportion of subjects reaching a
30% decrease in PTH did not differ. No effect on grip strength, fatigue, phosphate or fibroblast growth factor 23 was observed. Cholecalciferol treatment resulted in stable calcium concentrations and a substantial increase in calcitriol

Conclusion. Treatment with high daily doses of cholecalciferol in patients with CKD Stages 3–4 halts the progression of SHPT and does not cause hypercalcaemia or other side effects.
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