The effects of oral vitamin D supplementation on cardiovascular disease risk in patients with Myalgic Encephalomyelitis /Chronic Fatigue Syndrome. - Vitamin D supplementation in patients with ME/CFS

Conditions: Randomised, placebo controlled, parallel group, double blinded study to investigate if oral supplementation of vitamin D will improve vascular function and metabolic and inflammatory parameters in patients who have Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. We will investigate arterial stiffness and endothelial function in this group of patients.

Registration Number: EUCTR2010-019096-29-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients diagnosed with ME/CFS [fulfil the Fukuda (1994) and Canadian (2003)criteria]

Serum 25(OH)D levels <75 nmol/l
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients not diagnosed by consultant with ME/CFS
2.Patients already taking Vitamin D supplements (fish oils will be permitted)
3.Estimated GFR < 40 mls/min (by MDRD4 method)
4.Adjusted serum calcium <2.15 or > 2.60 mmol/L
5.LFTs > 3x upper limit of normal
6.Known metastatic malignancy
7.History of Kidney stones
8.History of sarcoidosis or Osteoporosis
9.Lying systolic BP < 80 mm Hg
10.Pregnant, lactating or of childbearing age and not taking reliable contraception
11.Patients diagnosed with psychiatric disorder within the past five years
12.Patients diagnosed with schizophrenia, mania, substance abuse/dependence, or an eating disorder at any time
13.Patients with other known organic cause for their symptoms
14.Unable to give written informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does high dose oral vitamin D improve the elasticity of the blood vessels in patients with ME/CFS? <br><br>The answer to this question will show whether vitamin D has any beneficial effect on blood vessel elasticity and therefore on the overall state of the cardiovascular system. The more elastic a blood vessel, then the healthier it is considered to be. ;Secondary Objective: Does high dose Vitamin D improve the health of the blood vessels, reduce inflammation and affect other blood tests that may be associated with poor blood vessel function?<br><br>Is the XMRV virus present in this population of ME/CFS patients and if so does it relate to markers of vascular function?;Primary end point(s): Changes in arterial stiffness between baseline and six months.

Secondary Outcome Measures