Myalgic Encephalomyelitis (ME)
Conditions
Interventions
In total there will be five visits in this study: screening, baseline visit, and visits during months 2, 4 and 6. The screening visit will involve taking written informed consent, a physical examinati
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial stiffness, assessed at baseline, 2 and 6 months: 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
| Measure | Time frame |
|---|---|
| 1. Endothelial function, assessed at baseline, 2 and 6 months: Flow-mediated dilation of the brachial artery will be measured according to standard guidelines. The diameter of the brachial artery will be measured using a 7.5-15 MHz linear array transducer. Baseline images are taken for 1 minute. A blood pressure cuff is then placed around the arm and inflated to a suprasystolic pressure for 5 minutes. ECG-triggered images are after captured for 3 minutes after cuff release. Once a stable baseline has been re-established, sublingual nitroglycerine (NTG) (0.4 mg) is administered and endothelium-independent vasodilation is assessed in a similar fashion. 2. Vascular biomarkers, assessed at baseline, 2 and 6 months 2.1. Fasting serum lipid profiles, measured using COBAS Bio Autoanalyser 2.2. Fasting glucose and insulin levels. Estimates of insulin resistance will be calculated using the Homeostasis Model (HOMA) (fasting glucose x fasting insulin/22.5). 2.3. High sensitivity C-reactive protein (CRP), measured by Enzyme Linked Immunosorbent Assay (ELISA) 2.4. Tumour necrosis factor-alpha (TNF-a), measured by ELISA 2.5. Interleukin-6 (IL-6), measured by ELISA 2.6. Serum 25-hydroxyvitamin D3 (25[OH]D), measured by ELISA 2.7. 1,25-dihydroxyvitamin D3 (1,25-[OH]2D3), measured by ELISA 3. Fatigue, measured using the Piper Fatigue Scale 4. Quality of life, assessed using the Medical Outcomes Study (MOS) SF-36 5. Emotional adjustment, assessed using the Hospital Anxiety and Depression Scale (HADS) | — |
Countries
United Kingdom
Outcome results
None listed