High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial.
Am J Clin Nutr. 2012 Aug 1.
Alvarez JA, Law J, Coakley KE, Zughaier SM, Hao L, Shahid Salles K, Wasse H, Gutiérrez OM, Ziegler TR, Tangpricha V.
Division of Endocrinology, Metabolism, and Lipids and the Division of Nephrology, Emory University School of Medicine, Atlanta, GA.
BACKGROUND: Vtamin 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.
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- Loading dose of 7100 IU daily average for 12 weeks
- Maintenance dose of 3500 IU daily average for additional 40 weeks
- PTH reduced from 90 to 70 pg/ml
- Overview Kidney and Vitamin D
- Kidney Conference had many Vitamin D papers – May 2012
- Need at least 80 ng of vitamin D if have chronic kidney disease – May 2012
- Adding Vitamin decreased kidney deaths by 4x – Dec 2010
It is amazing that such excellent results were buried in the paper. They were not in the title nor abstract.
This is the result of about 10 trials with about 5,000 kidney disease patients.
Note: some of the trials were terminated as they felt it was morally wrong to not give vitamin D to all of the Kidney patients
- All items in Kidney and Vitamin D
- 5700 IU of vitamin D helped half with chronic kidney disease if not having dialysis – July 2012
- Overview How Often to take vitamin D has the following notional chart