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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 Sep; 96(3):672-9.AJ

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.

Authors+Show Affiliations

Division of Endocrinology, Metabolism, and Lipids, Emory University School of Medicine, Atlanta, GA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22854402

Citation

Alvarez, Jessica A., et al. "High-dose Cholecalciferol Reduces Parathyroid Hormone in Patients With Early Chronic Kidney Disease: a Pilot, Randomized, Double-blind, Placebo-controlled Trial." The American Journal of Clinical Nutrition, vol. 96, no. 3, 2012, pp. 672-9.
Alvarez JA, Law J, Coakley KE, et al. 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;96(3):672-9.
Alvarez, J. A., Law, J., Coakley, K. E., Zughaier, S. M., Hao, L., Shahid Salles, K., Wasse, H., Gutiérrez, O. M., Ziegler, T. R., & Tangpricha, V. (2012). High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial. The American Journal of Clinical Nutrition, 96(3), 672-9. https://doi.org/10.3945/ajcn.112.040642
Alvarez JA, et al. 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;96(3):672-9. PubMed PMID: 22854402.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - High-dose cholecalciferol reduces parathyroid hormone in patients with early chronic kidney disease: a pilot, randomized, double-blind, placebo-controlled trial. AU - Alvarez,Jessica A, AU - Law,Jennie, AU - Coakley,Kathryn E, AU - Zughaier,Susu M, AU - Hao,Li, AU - Shahid Salles,Khadijeh, AU - Wasse,Haimanot, AU - Gutiérrez,Orlando M, AU - Ziegler,Thomas R, AU - Tangpricha,Vin, Y1 - 2012/08/01/ PY - 2012/8/3/entrez PY - 2012/8/3/pubmed PY - 2012/10/27/medline SP - 672 EP - 9 JF - The American journal of clinical nutrition JO - Am J Clin Nutr VL - 96 IS - 3 N2 - 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. SN - 1938-3207 UR - https://www.unboundmedicine.com/medline/citation/22854402/High_dose_cholecalciferol_reduces_parathyroid_hormone_in_patients_with_early_chronic_kidney_disease:_a_pilot_randomized_double_blind_placebo_controlled_trial_ L2 - https://academic.oup.com/ajcn/article-lookup/doi/10.3945/ajcn.112.040642 DB - PRIME DP - Unbound Medicine ER -