High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: A pilot, randomized, double-blind, placebo-controlled trial

Jessica A. Alvarez, Jennie Law, Kathryn E. Coakley, Susu M. Zughaier, Li Hao, Khadijeh Shahid Salles, Haimanot Wasse, Orlando M. Gutiérrez, Thomas R. Ziegler, Vin Tangpricha*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

78 Scopus citations

Abstract

Background: Vitamin D deficiency contributes to secondary hyperparathyroidism, which occurs early in chronic kidney disease (CKD). Objectives: We aimed to determine whether high-dose cholecalciferol supplementation for 1 y in early CKD is sufficient to maintain optimal vitamin D status (serum 25-hydroxyvitamin D [25(OH)D] concentration ≥30 ng/mL) and decrease serum parathyroid hormone (PTH). A secondary aim was to determine the effect of cholecalciferol on blood pressure and serum fibroblast growth factor-23 (FGF23). Design: This was a double-blind, randomized, placebo-controlled trial. Forty-six subjects with early CKD (stages 2-3) were supplemented with oral cholecalciferol (vitamin D group; 50,000 IU/wk for 12 wk followed by 50,000 IU every other week for 40 wk) or a matching placebo for 1 y. Results: By 12 wk, serum 25(OH)D increased in the vitamin D group only [baseline (mean ± SD): 26.7 ± 6.8 to 42.8 ± 16.9 ng/mL; P < 0.05] and remained elevated at 1 y (group-by-time interaction: P < 0.001). PTH decreased from baseline only in the vitamin D group (baseline: 89.1 ± 49.3 to 70.1 ± 24.8 pg/mL; P = 0.01) at 12 wk, but values were not significantly different from baseline at 1 y (75.4 ± 29.5 pg/mL; P = 0.16; group-by-time interaction: P = 0.09). Group differences were more pronounced in participants with secondary hyperparathyroidism (group-by-time interaction: P = 0.004). Blood pressure and FGF23 did not change in either group. Conclusions: After 1 y, this oral cholecalciferol regimen was safe and sufficient to maintain serum 25(OH)D concentrations and prevent vitamin D insufficiency in early CKD. Furthermore, serum PTH improved after cholecalciferol treatment, particularly in patients who had secondary hyperparathyroidism. This trial was registered at clinicaltrials.gov as NCT00427037.

Original languageEnglish (US)
Pages (from-to)672-679
Number of pages8
JournalAmerican Journal of Clinical Nutrition
Volume96
Issue number3
DOIs
StatePublished - Sep 1 2012

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Nutrition and Dietetics

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