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Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study
Liza Das1, Michael F Holick2, Naresh Sachdeva1, Sanjay Kumar Bhadada1, Shallu Singhmar1, Neetika Thakur1, Pinaki Dutta1, Raman Kumar Marwaha3
1 Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India
2 Department of Medicine, Section of Endocrinology, Diabetes, Nutrition and Weight Management, Boston University School of Medicine, Boston, Massachusetts, USA
3 Endocrinology, Society of Endocrine Health Care for Elderly, Adolescents and Children, New Delhi, India
Correspondence Address:
Pinaki Dutta
1012, Nehru Extension Block, PGIMER, Chandigarh - 160 012
India
BACKGROUND: Vitamin D deficiency (VDD) is highly prevalent across the globe. Cholecalciferol (Vitamin D3) fails to attain sufficient serum concentrations of 25-hydroxyvitamin D (25(OH)D) in a significant proportion of supplemented individuals. Calcifediol (25-hydroxyvitamin D3) is less studied in healthy adults and its effects on 25(OH)D, parathyroid hormone (PTH), and 1,25-dihydroxyvitamin D (1,25(OH)2D) at higher doses are not well known.
MATERIALS AND METHODS: The study was an open-label, interventional trial recruiting consecutive participants with VDD who were allocated to receive either 2 capsules (50 μg-group) or 1 capsule (25 μg-group) daily doses of calcifediol. Baseline assessment included clinicodemographic parameters, dietary calcium, calcemic (calcium, inorganic phosphate, albumin, alkaline phosphatase, urine spot calcium/creatinine), and hormonal parameters (25(OH)D, PTH, and 1,25(OH)2D). Participants were followed up at 4 and 8 weeks with repeat assessments of calcemic and hormonal parameters.
RESULTS: There were 64 participants, 35 (50 μg-group) and 29 (25 μg-group), without any significant difference in any of the baseline parameters. 97.1% participants in the 50 μg-group (at 4 and 8 weeks) and 93.1% (at 4 weeks) and 96.5% (at 8 weeks) in the 25 μg-group attained 25(OH)D sufficiency (≥30 ng/ml) with calcifediol. The mean serum 25(OH)D was 84.0 ± 27.7 ng/ml in the 50 μg-group and 58.0 ± 23.6 ng/ml in the 25 μg-group group at 4 weeks, which later rose to 94.3 ± 21.8 ng/ml and 76.0 ± 16.4 ng/ml, respectively, at 8 weeks. PTH levels decreased in both groups at both time points. 1,25(OH)2D rose significantly in both groups at 4 and 8 weeks but was not significantly different between both groups. There was no case of incident hypercalcemia or symptomatic nephrolithiasis.
CONCLUSION: Calcifediol is a safe and efficacious alternative for oral Vitamin D supplementation in young adults. Increment in 25(OH)D levels is rapid and dose-dependent.
How to cite this article:
Das L, Holick MF, Sachdeva N, Bhadada SK, Singhmar S, Thakur N, Dutta P, Marwaha RK. Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study.Indian J Pharmacol 2023;55:286-292
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How to cite this URL:
Das L, Holick MF, Sachdeva N, Bhadada SK, Singhmar S, Thakur N, Dutta P, Marwaha RK. Efficacy, safety, and dose-response effects of calcifediol supplementation on 25-hydroxyvitamin D, parathyroid hormone, and 1,25-dihydroxyvitamin D levels in healthy adults: An open-label, interventional pilot study. Indian J Pharmacol [serial online] 2023 [cited 2023 Nov 28 ];55:286-292
Available from: https://www.ijp-online.com/article.asp?issn=0253-7613;year=2023;volume=55;issue=5;spage=286;epage=292;aulast=Das;type=0 |
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