Highlights
- •We randomised 50 patients with CFS/ME to receive six months of intermittent high-dose vitamin D or placebo.
- •Vitamin D did not improve pulse-wave velocity or flow-mediated dilatation of the brachial artery compared to placebo.
- •Vitamin D did not improve markers of oxidative stress or inflammation compared to placebo.
- •Vitamin D did not improve symptoms of fatigue compared to placebo.
Abstract
Background and aims
Low 25-hydroxyvitamin D levels are common in patients with chronic fatigue syndrome;
such patients also manifest impaired vascular health. We tested whether high-dose
intermittent oral vitamin D therapy improved markers of vascular health and fatigue
in patients with chronic fatigue syndrome.
Methods and results
Parallel-group, double-blind, randomised placebo-controlled trial. Patients with chronic
fatigue syndrome according to the Fukuda (1994) and Canadian (2003) criteria were
randomised to receive 100,000 units oral vitamin D3 or matching placebo every 2 months
for 6 months. The primary outcome was arterial stiffness measured using carotid-femoral
pulse wave velocity at 6 months. Secondary outcomes included flow-mediated dilatation
of the brachial artery, blood pressure, cholesterol, insulin resistance, markers of
inflammation and oxidative stress, and the Piper Fatigue scale.
As many as 50 participants were randomised; mean age 49 (SD 13) years, mean baseline
pulse wave velocity 7.8 m/s (SD 2.3), mean baseline office blood pressure 128/78 (18/12)
mmHg and mean baseline 25-hydroxyvitamin D level 46 (18) nmol/L. 25-hydroxyvitamin
D levels increased by 22 nmol/L at 6 months in the treatment group relative to placebo.
There was no effect of treatment on pulse wave velocity at 6 months (adjusted treatment
effect 0.0 m/s; 95% CI −0.6 to 0.6; p = 0.93). No improvement was seen in other vascular and metabolic outcomes, or in
the Piper Fatigue scale at 6 months (adjusted treatment effect 0.2 points; 95% CI
−0.8 to 1.2; p = 0.73).
Conclusion
High-dose oral vitamin D3 did not improve markers of vascular health or fatigue in
patients with chronic fatigue syndrome.
Trial registration: www.controlled-trials.com, ISRCTN59927814.
Keywords
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Article Info
Publication History
Published online: October 22, 2014
Accepted:
October 14,
2014
Received in revised form:
October 1,
2014
Received:
August 2,
2014
Identification
Copyright
© 2014 Elsevier B.V. Published by Elsevier Inc. All rights reserved.

