Vitamin D and vascular health of chronic fatigue syndrome patients
- Conditions
- Myalgic Encephalomyelitis (ME)Chronic Fatigue Syndrome (CFS)Nervous System Diseases
- Registration Number
- ISRCTN59927814
- Lead Sponsor
- niversity of Dundee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
1. Patients diagnosed with ME/CFS (fulfils the Fukuda [1994] and Canadian [2003] criteria)
2. Serum 25(OH)D levels < 75 nmol/l
3. Male or female, aged 18 - 65
1. Patients not diagnosed with ME/CFS
2. Patients already taking Vitamin D supplements (fish oils will be permitted)
3. Estimated Glomerular Filtration Rate (GFR) < 40 ml/min (by MDRD4 method)
4. Adjusted serum calcium < 2.15 or > 2.60 mmol/L
5. Liver Function Test (LFT) > 3x upper limit of normal (ULN)
6. Known metastatic malignancy
7. History of kidney stones
8. History of sarcoidosis or osteoporosis
9. Lying systolic blood pressure (BP) < 80 mm Hg
10. Pregnant, lactating or of childbearing age and not taking reliable contraception
11. Patients diagnosed with psychiatric disorder (including depression) within the past 5 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Arterial stiffness, assessed at baseline, 2 and 6 months:<br>Blood pressure will be measured in triplicate using an automated blood pressure monitor (Omron705 CPII). Peripheral pressure waveforms will be recorded at the radial, femoral and carotid artery using the validated SphygmoCor pulse waveform analysis system (AtCor Medical). The carotid to femoral and carotid to radial pulse wave velocity will be calculated, and additionally the augmentation index.
- Secondary Outcome Measures
Name Time Method