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Effect of vitamin D3 on self-perceived fatigue


Abstract

Abstract
Background: Vitamin D deficiency is frequent and has been associated with fatigue in uncontrolled trials.
Methods:This is the first double-blind placebo-controlled clinical trial to investigate the efficacy of per os vitamin D3 (cholecalciferol)
in treating fatigue among otherwise healthy persons with low serum 25-hydroxyvitamin D (25(OH)D) levels. We enrolled 120
individuals (mean age 29±6 years, 53% women) presenting with fatigue and vitamin D deficiency (serum 25(OH)D<20mg/L).
Participants were randomized to a single oral dose of 100,000 units of vitamin D or placebo. The primary endpoint was intra-individual
change in the fatigue assessment scale (FAS) at 4 weeks after treatment.
Result: The mean age of the participants was 29±6 years, 53% were women. Mean FAS decreased significantly more in the vitamin
D group (�3.3±5.3; 95% confidence interval [CI] for change �14.1 to 4.1) compared with placebo (�0.8±5.3; 95% CI for change
�9.0 to 8.7); (P=0.01). Amelioration of fatigue was reported more frequently in vitamin D than in placebo group (42 [72%] vs. 31
[50%]; P=0.01; odds ratio [OR] 2.63, 95% CI for OR 1.23–5.62). Among all participants, improvement in fatigue score correlated
with the rise in 25(OH)D level (R=�0.22, P=0.02).
Conclusion: Vitamin D treatment significantly improved fatigue in otherwise healthy persons with vitamin D deficiency.
This study was registered at the www.ClinicalTrials.gov Protocol ID NCT02022475.
Abbreviations: 25(OH)D = 25-hydroxyvitamin D, BDI = beck depression inventory, BMI = body mass index, BQF = basic
questionnaire for fatigue, CFS = chronic fatigue syndrome, FAS = fatigue assessment scale, FCA = fatigue course assessment, IQR
= interquartile range, ISI = insomnia severity index, IU = international unit, M.I.N.I = mini international neuropsychiatric interview, MD =
medical doctor, OR = odds ratio, PTH = parathyroid hormone, RCT = randomized clinical trial, TSH = thyroid stimulating hormone.
Keywords: fatigue, randomized clinical trial, vitamin D

Abstract

Abstract
Background: Vitamin D deficiency is frequent and has been associated with fatigue in uncontrolled trials.
Methods:This is the first double-blind placebo-controlled clinical trial to investigate the efficacy of per os vitamin D3 (cholecalciferol)
in treating fatigue among otherwise healthy persons with low serum 25-hydroxyvitamin D (25(OH)D) levels. We enrolled 120
individuals (mean age 29±6 years, 53% women) presenting with fatigue and vitamin D deficiency (serum 25(OH)D<20mg/L).
Participants were randomized to a single oral dose of 100,000 units of vitamin D or placebo. The primary endpoint was intra-individual
change in the fatigue assessment scale (FAS) at 4 weeks after treatment.
Result: The mean age of the participants was 29±6 years, 53% were women. Mean FAS decreased significantly more in the vitamin
D group (�3.3±5.3; 95% confidence interval [CI] for change �14.1 to 4.1) compared with placebo (�0.8±5.3; 95% CI for change
�9.0 to 8.7); (P=0.01). Amelioration of fatigue was reported more frequently in vitamin D than in placebo group (42 [72%] vs. 31
[50%]; P=0.01; odds ratio [OR] 2.63, 95% CI for OR 1.23–5.62). Among all participants, improvement in fatigue score correlated
with the rise in 25(OH)D level (R=�0.22, P=0.02).
Conclusion: Vitamin D treatment significantly improved fatigue in otherwise healthy persons with vitamin D deficiency.
This study was registered at the www.ClinicalTrials.gov Protocol ID NCT02022475.
Abbreviations: 25(OH)D = 25-hydroxyvitamin D, BDI = beck depression inventory, BMI = body mass index, BQF = basic
questionnaire for fatigue, CFS = chronic fatigue syndrome, FAS = fatigue assessment scale, FCA = fatigue course assessment, IQR
= interquartile range, ISI = insomnia severity index, IU = international unit, M.I.N.I = mini international neuropsychiatric interview, MD =
medical doctor, OR = odds ratio, PTH = parathyroid hormone, RCT = randomized clinical trial, TSH = thyroid stimulating hormone.
Keywords: fatigue, randomized clinical trial, vitamin D

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Contributors:Department of Internal Medicine, Spital Linth, Uznach, Switzerland
Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > University Hospital Zurich > Clinic and Policlinic for Internal Medicine
04 Faculty of Medicine > University Hospital Zurich > Institute of Clinical Chemistry
04 Faculty of Medicine > University Hospital Zurich > Clinic for Endocrinology and Diabetology
04 Faculty of Medicine > University Hospital Zurich > Clinic for Geriatric Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2016
Deposited On:03 Jan 2017 09:29
Last Modified:03 Jan 2017 09:29
Publisher:Lippincott Williams & Wilkins
ISSN:0025-7974
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1097/MD.0000000000005353

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