Dose response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults

Anouk M. M. Vaes; Michael Tieland; Margot F. de Regt; Jonas Wittwer; Luc J. C. van Loon; Lisette C. P. G. M. de Groot

doi:10.1016/j.clnu.2017.03.029

Dose response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults

Anouk M. M. Vaes^*, Michael Tieland, Margot F. de Regt, Jonas Wittwer, Luc J. C. van Loon, Lisette C. P. G. M. de Groot

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background & aims: Oral supplementation with vitamin D is recommended for older adults to maintain a sufficient 25-hydroxyvitamin D (25(OH)D) status throughout the year. While supplementation with vitamin D-2 or D-3 is most common, alternative treatment regimens exist which require further investigation with respect to increasing 25(OH)D concentration. We investigated the dose response effects of supplementation with calcifediol compared to vitamin D-3 and assessed the dose which results in mean serum 25(OH)D-3 concentrations between 75 and 100 nmol/L.

Methods: This randomized, double-blind intervention study included men and women aged >= 65 years (n = 59). Participants received either 5, 10 or 15 mu g calcifediol or 20 mu g vitamin D-3 per day, for a period of 24 weeks. Blood samples were collected every four weeks to assess response profiles of vitamin D related metabolites; serum vitamin D-3, 25(OH)D-3, 1,25-dihydroxyvitamin D-3 (1,25(OH)(2)D-3) and 24,25-dihydroxyvitamin D-3 (24,25(OH)(2)D-3). Further, serum calcium, plasma parathyroid hormone, and urinary calcium were evaluated.

Results: Supplementation with 20 jig vitamin 03 increased 25(OH)D-3 concentrations towards 70 nmol/L within 16 weeks. Supplementation with 10 or 15 mu g calcifediol increased 25(OH)D-3 levels >75 nmol/L in 8 and 4 weeks, respectively. Steady state was achieved from week 12 onwards with serum 25(OH)D-3 levels stabilizing between 84 and 89 nmol/L in the 10 mu g calcifediol group. A significant association was observed between the changes in 25(OH)D-3 and 24,25(OH)(2)D-3 (R-2 = 0.83, P <0.01), but not between 25(OH)D-3 and 1,25(OH)(2)D-3 (R-2 = 0.04, P = 0.18). No cases of hypercalcemia occurred in any treatment during the study period.

Conclusions: Calcifediol supplementation rapidly and safely elevates serum 25(OH)D-3 concentrations to improve vitamin D status in older adults. A daily dose of 10 mu g calcifediol allows serum 25(OH)D-3 concentrations to be maintained between 75 and 100 nmol/L.

Original language	English
Pages (from-to)	808-814
Number of pages	7
Journal	Clinical Nutrition
Volume	37
Issue number	3
DOIs	https://doi.org/10.1016/j.clnu.2017.03.029
Publication status	Published - Jun 2018

Keywords

Vitamin D
Calcifediol
Dose response
Supplementation
25-Hydroxyvitamin D
PTH
VITAMIN-D DEFICIENCY
HUMAN-SKIN
25-HYDROXYCHOLECALCIFEROL
FREQUENCY
D-3
25(OH)D
SOCIETY
WOMEN
FOOD
AGE

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10.1016/j.clnu.2017.03.029

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@article{8843c38b4d6c4d3498d5cc70ddae7c9b,

title = "Dose response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults",

abstract = "Background & aims: Oral supplementation with vitamin D is recommended for older adults to maintain a sufficient 25-hydroxyvitamin D (25(OH)D) status throughout the year. While supplementation with vitamin D-2 or D-3 is most common, alternative treatment regimens exist which require further investigation with respect to increasing 25(OH)D concentration. We investigated the dose response effects of supplementation with calcifediol compared to vitamin D-3 and assessed the dose which results in mean serum 25(OH)D-3 concentrations between 75 and 100 nmol/L.Methods: This randomized, double-blind intervention study included men and women aged >= 65 years (n = 59). Participants received either 5, 10 or 15 mu g calcifediol or 20 mu g vitamin D-3 per day, for a period of 24 weeks. Blood samples were collected every four weeks to assess response profiles of vitamin D related metabolites; serum vitamin D-3, 25(OH)D-3, 1,25-dihydroxyvitamin D-3 (1,25(OH)(2)D-3) and 24,25-dihydroxyvitamin D-3 (24,25(OH)(2)D-3). Further, serum calcium, plasma parathyroid hormone, and urinary calcium were evaluated.Results: Supplementation with 20 jig vitamin 03 increased 25(OH)D-3 concentrations towards 70 nmol/L within 16 weeks. Supplementation with 10 or 15 mu g calcifediol increased 25(OH)D-3 levels >75 nmol/L in 8 and 4 weeks, respectively. Steady state was achieved from week 12 onwards with serum 25(OH)D-3 levels stabilizing between 84 and 89 nmol/L in the 10 mu g calcifediol group. A significant association was observed between the changes in 25(OH)D-3 and 24,25(OH)(2)D-3 (R-2 = 0.83, P <0.01), but not between 25(OH)D-3 and 1,25(OH)(2)D-3 (R-2 = 0.04, P = 0.18). No cases of hypercalcemia occurred in any treatment during the study period.Conclusions: Calcifediol supplementation rapidly and safely elevates serum 25(OH)D-3 concentrations to improve vitamin D status in older adults. A daily dose of 10 mu g calcifediol allows serum 25(OH)D-3 concentrations to be maintained between 75 and 100 nmol/L.Trial registration number: NCT01868945. (C) 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.",

keywords = "Vitamin D, Calcifediol, Dose response, Supplementation, 25-Hydroxyvitamin D, PTH, VITAMIN-D DEFICIENCY, HUMAN-SKIN, 25-HYDROXYCHOLECALCIFEROL, FREQUENCY, D-3, 25(OH)D, SOCIETY, WOMEN, FOOD, AGE",

author = "Vaes, {Anouk M. M.} and Michael Tieland and {de Regt}, {Margot F.} and Jonas Wittwer and {van Loon}, {Luc J. C.} and {de Groot}, {Lisette C. P. G. M.}",

year = "2018",

month = jun,

doi = "10.1016/j.clnu.2017.03.029",

language = "English",

volume = "37",

pages = "808--814",

journal = "Clinical Nutrition",

issn = "0261-5614",

publisher = "Churchill Livingstone",

number = "3",

}

TY - JOUR

T1 - Dose response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites

T2 - A randomized controlled trial in older adults

AU - Vaes, Anouk M. M.

AU - Tieland, Michael

AU - de Regt, Margot F.

AU - Wittwer, Jonas

AU - van Loon, Luc J. C.

AU - de Groot, Lisette C. P. G. M.

PY - 2018/6

Y1 - 2018/6

N2 - Background & aims: Oral supplementation with vitamin D is recommended for older adults to maintain a sufficient 25-hydroxyvitamin D (25(OH)D) status throughout the year. While supplementation with vitamin D-2 or D-3 is most common, alternative treatment regimens exist which require further investigation with respect to increasing 25(OH)D concentration. We investigated the dose response effects of supplementation with calcifediol compared to vitamin D-3 and assessed the dose which results in mean serum 25(OH)D-3 concentrations between 75 and 100 nmol/L.Methods: This randomized, double-blind intervention study included men and women aged >= 65 years (n = 59). Participants received either 5, 10 or 15 mu g calcifediol or 20 mu g vitamin D-3 per day, for a period of 24 weeks. Blood samples were collected every four weeks to assess response profiles of vitamin D related metabolites; serum vitamin D-3, 25(OH)D-3, 1,25-dihydroxyvitamin D-3 (1,25(OH)(2)D-3) and 24,25-dihydroxyvitamin D-3 (24,25(OH)(2)D-3). Further, serum calcium, plasma parathyroid hormone, and urinary calcium were evaluated.Results: Supplementation with 20 jig vitamin 03 increased 25(OH)D-3 concentrations towards 70 nmol/L within 16 weeks. Supplementation with 10 or 15 mu g calcifediol increased 25(OH)D-3 levels >75 nmol/L in 8 and 4 weeks, respectively. Steady state was achieved from week 12 onwards with serum 25(OH)D-3 levels stabilizing between 84 and 89 nmol/L in the 10 mu g calcifediol group. A significant association was observed between the changes in 25(OH)D-3 and 24,25(OH)(2)D-3 (R-2 = 0.83, P <0.01), but not between 25(OH)D-3 and 1,25(OH)(2)D-3 (R-2 = 0.04, P = 0.18). No cases of hypercalcemia occurred in any treatment during the study period.Conclusions: Calcifediol supplementation rapidly and safely elevates serum 25(OH)D-3 concentrations to improve vitamin D status in older adults. A daily dose of 10 mu g calcifediol allows serum 25(OH)D-3 concentrations to be maintained between 75 and 100 nmol/L.Trial registration number: NCT01868945. (C) 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

AB - Background & aims: Oral supplementation with vitamin D is recommended for older adults to maintain a sufficient 25-hydroxyvitamin D (25(OH)D) status throughout the year. While supplementation with vitamin D-2 or D-3 is most common, alternative treatment regimens exist which require further investigation with respect to increasing 25(OH)D concentration. We investigated the dose response effects of supplementation with calcifediol compared to vitamin D-3 and assessed the dose which results in mean serum 25(OH)D-3 concentrations between 75 and 100 nmol/L.Methods: This randomized, double-blind intervention study included men and women aged >= 65 years (n = 59). Participants received either 5, 10 or 15 mu g calcifediol or 20 mu g vitamin D-3 per day, for a period of 24 weeks. Blood samples were collected every four weeks to assess response profiles of vitamin D related metabolites; serum vitamin D-3, 25(OH)D-3, 1,25-dihydroxyvitamin D-3 (1,25(OH)(2)D-3) and 24,25-dihydroxyvitamin D-3 (24,25(OH)(2)D-3). Further, serum calcium, plasma parathyroid hormone, and urinary calcium were evaluated.Results: Supplementation with 20 jig vitamin 03 increased 25(OH)D-3 concentrations towards 70 nmol/L within 16 weeks. Supplementation with 10 or 15 mu g calcifediol increased 25(OH)D-3 levels >75 nmol/L in 8 and 4 weeks, respectively. Steady state was achieved from week 12 onwards with serum 25(OH)D-3 levels stabilizing between 84 and 89 nmol/L in the 10 mu g calcifediol group. A significant association was observed between the changes in 25(OH)D-3 and 24,25(OH)(2)D-3 (R-2 = 0.83, P <0.01), but not between 25(OH)D-3 and 1,25(OH)(2)D-3 (R-2 = 0.04, P = 0.18). No cases of hypercalcemia occurred in any treatment during the study period.Conclusions: Calcifediol supplementation rapidly and safely elevates serum 25(OH)D-3 concentrations to improve vitamin D status in older adults. A daily dose of 10 mu g calcifediol allows serum 25(OH)D-3 concentrations to be maintained between 75 and 100 nmol/L.Trial registration number: NCT01868945. (C) 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

KW - Vitamin D

KW - Calcifediol

KW - Dose response

KW - Supplementation

KW - 25-Hydroxyvitamin D

KW - PTH

KW - VITAMIN-D DEFICIENCY

KW - HUMAN-SKIN

KW - 25-HYDROXYCHOLECALCIFEROL

KW - FREQUENCY

KW - D-3

KW - 25(OH)D

KW - SOCIETY

KW - WOMEN

KW - FOOD

KW - AGE

U2 - 10.1016/j.clnu.2017.03.029

DO - 10.1016/j.clnu.2017.03.029

M3 - Article

SN - 0261-5614

VL - 37

SP - 808

EP - 814

JO - Clinical Nutrition

JF - Clinical Nutrition

IS - 3

ER -