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Randomized Controlled Trial
. 2016 Dec;95(52):e5353.
doi: 10.1097/MD.0000000000005353.

Effect of Vitamin D3 on Self-Perceived Fatigue: A Double-Blind Randomized Placebo-Controlled Trial

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Free PMC article
Randomized Controlled Trial

Effect of Vitamin D3 on Self-Perceived Fatigue: A Double-Blind Randomized Placebo-Controlled Trial

Albina Nowak et al. Medicine (Baltimore). .
Free PMC article

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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 < 20 μg/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.

Conflict of interest statement

The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Change of fatigue assessment scale depending on the administration of vitamin D or placebo (dotted lines correspond to means).
Figure 2
Figure 2
Fatigue at baseline and after 4 weeks in the vitamin D-treated and placebo-treated group (dotted lines correspond to means).

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