A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity?

A D Wood; K R Secombes; F Thies; L S Aucott; A J Black; D M Reid; A Mavroeidi; W G Simpson; W D Fraser; H M Macdonald

doi:10.1007/s00198-013-2473-8

A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity?

A D Wood, K R Secombes, F Thies, L S Aucott, A J Black, D M Reid, A Mavroeidi, W G Simpson, W D Fraser, H M Macdonald

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

32 Citations (Scopus)

Abstract

Vitamin D may affect skeletal muscle function. In a double-blind, randomised, placebo-controlled trial, we found that vitamin D-3 supplementation (400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits) does not improve grip strength or reduce falls.

This study aimed to test the supplementation effects of vitamin D-3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment.

In a parallel group double-blind RCT, healthy postmenopausal women from North East Scotland (latitude-57A degrees N) aged 60-70 years (body mass index (BMI), 18-45 kg/m(2)) were assigned (computer randomisation) to daily vitamin D-3 (400 I.U. (n = 102)/1,000 I.U. (n = 101)) or matching placebo (n = 102) (97, 96 and 100 participants analysed for outcomes, respectively) from identical coded containers for 1 year. Grip strength (primary outcome), falls, diet, physical activity and ultraviolet B radiation exposure were measured bimonthly, as were serum 25(OH)D, adjusted calcium (ACa) and phosphate. Fat/lean mass (dual energy X-ray absorptiometry), anthropometry, 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months. Participants and researchers were blinded throughout intervention and analysis.

Treatment had no effect on grip strength (mean change (SD)/year = -0.5 (2.5), -0.9 (2.7) and -0.4 (3.3) kg force for 400/1,000 I.U. vitamin D-3 and placebo groups, respectively (P = .10, ANOVA)) or falls (P = .65, chi-squared test). Biochemical responses were similar across BMI categories (<25.25-29.99, a parts per thousand yen30 kg/m(2)) with the exception of a small change at 12-months in serum ACa in overweight compared to non-overweight participants (P = .01, ANOVA; 1,000 I.U. group). In the placebo group, 25(OH)D peak concentration change (winter to summer) was negatively associated with weight (r = -.268), BMI (r = -.198), total (r = -.278) and trunk fat mass (r = -.251), with total and trunk fat mass predictive of winter to summer 25(OH)D change (P = .01/.004 respectively, linear regression).

We found no evidence of an improvement in physical function following vitamin D-3 supplementation for 1 year.

Original language	English
Pages (from-to)	305-315
Number of pages	11
Journal	Osteoporosis International
Volume	25
Issue number	1
Early online date	28 Aug 2013
DOIs	https://doi.org/10.1007/s00198-013-2473-8
Publication status	Published - Jan 2014

Bibliographical note

This work was funded partly by the UK Food Standards Agency, the Department of Health and the National Osteoporosis Society. Any views expressed are the authors own. We thank Mrs. Lismy Cheripelli (Registered General Nurse, University of Aberdeen, UK) who made significant contributions to the acquisition of data and the continued welfare of our study participants; Prof. Roger Francis (University of Newcastle, UK) for his role as Trial Steering Committee Chair; Prof. Juliet Compston (University of Cambridge, UK) and Prof. Bernard Keavney and Dr. Mark Pearce (both of University of Newcastle, UK) as members of the Data Monitoring Committee; Mrs. Gladys McPherson (University of Aberdeen, UK), for providing randomization service, generating study codes to ensure blinding throughout data analysis, and performing code breaks after analysis; Ms. Katie Wilde (University of Aberdeen, UK) for developing and maintaining our electronic study database; Mrs. Lana Gibson (University of Aberdeen, UK) and Mrs. Jennifer Scott (University of Aberdeen, UK) for performing DXA scans; Mr. William Mutch (University of Aberdeen, UK) for contribution to biochemical analyses, and Ms Katrina Galbreith for help with data entry. Finally, we would like to thank all of the women who took part in our study.

Keywords

Accidental Falls
Aged
Anthropometry
Body Composition
Body Mass Index
Calcium
Cholecalciferol
Diet
Dietary Supplements
Dose-Response Relationship, Drug
Double-Blind Method
Female
Hand Strength
Humans
Middle Aged
Motor Activity
Obesity
Overweight
Phosphates
Sunlight
Vitamin D
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Wood, A. D., Secombes, K. R., Thies, F., Aucott, L. S., Black, A. J., Reid, D. M., Mavroeidi, A., Simpson, W. G., Fraser, W. D., & Macdonald, H. M. (2014). A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity? Osteoporosis International, 25(1), 305-315. https://doi.org/10.1007/s00198-013-2473-8

Wood, AD, Secombes, KR, Thies, F , Aucott, LS, Black, AJ, Reid, DM, Mavroeidi, A, Simpson, WG, Fraser, WD & Macdonald, HM 2014, 'A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity?', Osteoporosis International, vol. 25, no. 1, pp. 305-315. https://doi.org/10.1007/s00198-013-2473-8

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title = "A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity?",

abstract = "Vitamin D may affect skeletal muscle function. In a double-blind, randomised, placebo-controlled trial, we found that vitamin D-3 supplementation (400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits) does not improve grip strength or reduce falls.This study aimed to test the supplementation effects of vitamin D-3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment.In a parallel group double-blind RCT, healthy postmenopausal women from North East Scotland (latitude-57A degrees N) aged 60-70 years (body mass index (BMI), 18-45 kg/m(2)) were assigned (computer randomisation) to daily vitamin D-3 (400 I.U. (n = 102)/1,000 I.U. (n = 101)) or matching placebo (n = 102) (97, 96 and 100 participants analysed for outcomes, respectively) from identical coded containers for 1 year. Grip strength (primary outcome), falls, diet, physical activity and ultraviolet B radiation exposure were measured bimonthly, as were serum 25(OH)D, adjusted calcium (ACa) and phosphate. Fat/lean mass (dual energy X-ray absorptiometry), anthropometry, 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months. Participants and researchers were blinded throughout intervention and analysis.Treatment had no effect on grip strength (mean change (SD)/year = -0.5 (2.5), -0.9 (2.7) and -0.4 (3.3) kg force for 400/1,000 I.U. vitamin D-3 and placebo groups, respectively (P = .10, ANOVA)) or falls (P = .65, chi-squared test). Biochemical responses were similar across BMI categories (<25.25-29.99, a parts per thousand yen30 kg/m(2)) with the exception of a small change at 12-months in serum ACa in overweight compared to non-overweight participants (P = .01, ANOVA; 1,000 I.U. group). In the placebo group, 25(OH)D peak concentration change (winter to summer) was negatively associated with weight (r = -.268), BMI (r = -.198), total (r = -.278) and trunk fat mass (r = -.251), with total and trunk fat mass predictive of winter to summer 25(OH)D change (P = .01/.004 respectively, linear regression).We found no evidence of an improvement in physical function following vitamin D-3 supplementation for 1 year.",

keywords = "Accidental Falls, Aged, Anthropometry, Body Composition, Body Mass Index, Calcium, Cholecalciferol, Diet, Dietary Supplements, Dose-Response Relationship, Drug, Double-Blind Method, Female, Hand Strength, Humans, Middle Aged, Motor Activity, Obesity, Overweight, Phosphates, Sunlight, Vitamin D, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't",

author = "Wood, {A D} and Secombes, {K R} and F Thies and Aucott, {L S} and Black, {A J} and Reid, {D M} and A Mavroeidi and Simpson, {W G} and Fraser, {W D} and Macdonald, {H M}",

note = "This work was funded partly by the UK Food Standards Agency, the Department of Health and the National Osteoporosis Society. Any views expressed are the authors own. We thank Mrs. Lismy Cheripelli (Registered General Nurse, University of Aberdeen, UK) who made significant contributions to the acquisition of data and the continued welfare of our study participants; Prof. Roger Francis (University of Newcastle, UK) for his role as Trial Steering Committee Chair; Prof. Juliet Compston (University of Cambridge, UK) and Prof. Bernard Keavney and Dr. Mark Pearce (both of University of Newcastle, UK) as members of the Data Monitoring Committee; Mrs. Gladys McPherson (University of Aberdeen, UK), for providing randomization service, generating study codes to ensure blinding throughout data analysis, and performing code breaks after analysis; Ms. Katie Wilde (University of Aberdeen, UK) for developing and maintaining our electronic study database; Mrs. Lana Gibson (University of Aberdeen, UK) and Mrs. Jennifer Scott (University of Aberdeen, UK) for performing DXA scans; Mr. William Mutch (University of Aberdeen, UK) for contribution to biochemical analyses, and Ms Katrina Galbreith for help with data entry. Finally, we would like to thank all of the women who took part in our study.",

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T1 - A parallel group double-blind RCT of vitamin D3 assessing physical function

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AU - Simpson, W G

AU - Fraser, W D

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N1 - This work was funded partly by the UK Food Standards Agency, the Department of Health and the National Osteoporosis Society. Any views expressed are the authors own. We thank Mrs. Lismy Cheripelli (Registered General Nurse, University of Aberdeen, UK) who made significant contributions to the acquisition of data and the continued welfare of our study participants; Prof. Roger Francis (University of Newcastle, UK) for his role as Trial Steering Committee Chair; Prof. Juliet Compston (University of Cambridge, UK) and Prof. Bernard Keavney and Dr. Mark Pearce (both of University of Newcastle, UK) as members of the Data Monitoring Committee; Mrs. Gladys McPherson (University of Aberdeen, UK), for providing randomization service, generating study codes to ensure blinding throughout data analysis, and performing code breaks after analysis; Ms. Katie Wilde (University of Aberdeen, UK) for developing and maintaining our electronic study database; Mrs. Lana Gibson (University of Aberdeen, UK) and Mrs. Jennifer Scott (University of Aberdeen, UK) for performing DXA scans; Mr. William Mutch (University of Aberdeen, UK) for contribution to biochemical analyses, and Ms Katrina Galbreith for help with data entry. Finally, we would like to thank all of the women who took part in our study.

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N2 - Vitamin D may affect skeletal muscle function. In a double-blind, randomised, placebo-controlled trial, we found that vitamin D-3 supplementation (400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits) does not improve grip strength or reduce falls.This study aimed to test the supplementation effects of vitamin D-3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment.In a parallel group double-blind RCT, healthy postmenopausal women from North East Scotland (latitude-57A degrees N) aged 60-70 years (body mass index (BMI), 18-45 kg/m(2)) were assigned (computer randomisation) to daily vitamin D-3 (400 I.U. (n = 102)/1,000 I.U. (n = 101)) or matching placebo (n = 102) (97, 96 and 100 participants analysed for outcomes, respectively) from identical coded containers for 1 year. Grip strength (primary outcome), falls, diet, physical activity and ultraviolet B radiation exposure were measured bimonthly, as were serum 25(OH)D, adjusted calcium (ACa) and phosphate. Fat/lean mass (dual energy X-ray absorptiometry), anthropometry, 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months. Participants and researchers were blinded throughout intervention and analysis.Treatment had no effect on grip strength (mean change (SD)/year = -0.5 (2.5), -0.9 (2.7) and -0.4 (3.3) kg force for 400/1,000 I.U. vitamin D-3 and placebo groups, respectively (P = .10, ANOVA)) or falls (P = .65, chi-squared test). Biochemical responses were similar across BMI categories (<25.25-29.99, a parts per thousand yen30 kg/m(2)) with the exception of a small change at 12-months in serum ACa in overweight compared to non-overweight participants (P = .01, ANOVA; 1,000 I.U. group). In the placebo group, 25(OH)D peak concentration change (winter to summer) was negatively associated with weight (r = -.268), BMI (r = -.198), total (r = -.278) and trunk fat mass (r = -.251), with total and trunk fat mass predictive of winter to summer 25(OH)D change (P = .01/.004 respectively, linear regression).We found no evidence of an improvement in physical function following vitamin D-3 supplementation for 1 year.

AB - Vitamin D may affect skeletal muscle function. In a double-blind, randomised, placebo-controlled trial, we found that vitamin D-3 supplementation (400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits) does not improve grip strength or reduce falls.This study aimed to test the supplementation effects of vitamin D-3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment.In a parallel group double-blind RCT, healthy postmenopausal women from North East Scotland (latitude-57A degrees N) aged 60-70 years (body mass index (BMI), 18-45 kg/m(2)) were assigned (computer randomisation) to daily vitamin D-3 (400 I.U. (n = 102)/1,000 I.U. (n = 101)) or matching placebo (n = 102) (97, 96 and 100 participants analysed for outcomes, respectively) from identical coded containers for 1 year. Grip strength (primary outcome), falls, diet, physical activity and ultraviolet B radiation exposure were measured bimonthly, as were serum 25(OH)D, adjusted calcium (ACa) and phosphate. Fat/lean mass (dual energy X-ray absorptiometry), anthropometry, 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months. Participants and researchers were blinded throughout intervention and analysis.Treatment had no effect on grip strength (mean change (SD)/year = -0.5 (2.5), -0.9 (2.7) and -0.4 (3.3) kg force for 400/1,000 I.U. vitamin D-3 and placebo groups, respectively (P = .10, ANOVA)) or falls (P = .65, chi-squared test). Biochemical responses were similar across BMI categories (<25.25-29.99, a parts per thousand yen30 kg/m(2)) with the exception of a small change at 12-months in serum ACa in overweight compared to non-overweight participants (P = .01, ANOVA; 1,000 I.U. group). In the placebo group, 25(OH)D peak concentration change (winter to summer) was negatively associated with weight (r = -.268), BMI (r = -.198), total (r = -.278) and trunk fat mass (r = -.251), with total and trunk fat mass predictive of winter to summer 25(OH)D change (P = .01/.004 respectively, linear regression).We found no evidence of an improvement in physical function following vitamin D-3 supplementation for 1 year.

KW - Accidental Falls

KW - Aged

KW - Anthropometry

KW - Body Composition

KW - Body Mass Index

KW - Calcium

KW - Cholecalciferol

KW - Diet

KW - Dietary Supplements

KW - Dose-Response Relationship, Drug

KW - Double-Blind Method

KW - Female

KW - Hand Strength

KW - Humans

KW - Middle Aged

KW - Motor Activity

KW - Obesity

KW - Overweight

KW - Phosphates

KW - Sunlight

KW - Vitamin D

KW - Journal Article

KW - Randomized Controlled Trial

KW - Research Support, Non-U.S. Gov't

U2 - 10.1007/s00198-013-2473-8

DO - 10.1007/s00198-013-2473-8

M3 - Article

C2 - 23982800

SN - 0937-941X

VL - 25

SP - 305

EP - 315

JO - Osteoporosis International

JF - Osteoporosis International

IS - 1

ER -

A parallel group double-blind RCT of vitamin D3 assessing physical function: is the biochemical response to treatment affected by overweight and obesity?

Abstract

Bibliographical note

Keywords

UN SDGs

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