Vitamin D and vascular health of chronic fatigue syndrome patients
| ISRCTN | ISRCTN59927814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59927814 |
| Clinical Trials Information System (CTIS) | 2010-019096-29 |
| Protocol serial number | 2009CV08 |
| Sponsor | University of Dundee |
| Funder | ME Research UK (UK) |
- Submission date
- 10/02/2010
- Registration date
- 18/03/2010
- Last edited
- 01/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Vitamin D levels are commonly low in patients with chronic fatigue syndrome and these patients can also have poor vascular health. The aim of this study is to test whether high-dose intermittent oral vitamin D therapy given every two months for six months could improve markers of vascular health and fatigue in patients with chronic fatigue syndrome.
Who can participate?
Patients aged 18 - 65 with chronic fatigue syndrome
What does the study involve?
Participants are randomly allocated to receive 100,000 units oral vitamin D3 or a matching placebo (dummy) treatment every 2 months for 6 months. Blood vessel function is assessed using non-invasive methods at a visit before receiving vitamin D3 and at the final 6-month visit. Other tests undertaken by participants are flow-mediated dilatation of the brachial artery; blood pressure, cholesterol, insulin resistance, markers of inflammation and oxidative stress are tested at the start of the study and repeated at 6 months, and each participant completes a fatigue questionnaire before and after 6 months in the study.
What are the possible benefits and risks of participating?
Potential risks of taking part include a risk of low calcium blood levels with high dose vitamin D3 but participants are monitored regularly.
Where is the study run from?
Ninewells Hospital (UK)
When is the study starting and how long is it expected to run for?
April 2010 to April 2011
Who is funding the study?
ME Research UK
Who is the main contact?
Prof. JJF Belch
Contact information
Scientific
The Institute of Cardiovascular Research
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo-controlled parallel-group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Vitamin D supplementation in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) patients: a randomised, placebo-controlled, parallel, double-blind study |
| Study objectives | Serum concentration of 25-hydroxyvitamin D (25[OH]D) levels are associated with important cardiovascular risk factors. Low levels of 25(OH)D are associated with hypertension, increased vascular resistance, increased left ventricular mass index, and increased coronary calcification. Correlation between levels of inflammation and arterial stiffness has been reported in a population of 41 well-characterised patients with ME/CFS compared to 30 healthy subjects but vitamin D levels were not measured as part of that study done by University of Dundee. This study will investigate the relationship between vitamin D and arterial stiffness and inflammation and further examine various parts of the vitamin D pathway. |
| Ethics approval(s) | Fife & Forth Valley Research Ethics Committee 2 (now called East of Scotland Research Ethics Service REC 2), 15/02/2011, REC ref: 10/SO501/61 |
| Health condition(s) or problem(s) studied | Myalgic Encephalomyelitis (ME); Chronic Fatigue Syndrome (CFS) |
| Intervention | 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 examination, medical history to diagnose CFS and to check inclusion/exclusion criteria. The baseline visit will involve dosing of 100,000 unit of cholecalciferol or matching placebo and taking blood for baseline biomarkers, Peripheral Arterial Tonometry (PAT), blood pressure (BP) and electrocardiography (ECG). The dose of cholecalciferol will be repeated during the 2nd and 4th month visits. Activities during 2nd month and 6th month visit will be identical to the baseline visit. The 4th month visit will involve only dosing and review of adverse events (AE). The total duration of this study is 18 months. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Arterial stiffness, assessed at baseline, 2 and 6 months: |
| Key secondary outcome measure(s) |
1. Endothelial function, assessed at baseline, 2 and 6 months: |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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) < 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 |
| Date of first enrolment | 01/08/2011 |
| Date of final enrolment | 01/03/2012 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Faisel Khan (f.khan@dundee.ac.uk). Access to data will be subject to entering into collaboration with the investigators for non-commercial, bona fide academic analyses; decisions on data access will be made between the investigators and the Sponsor (University of Dundee). Participant consent for unrestricted sharing of individual participant data was not obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | Yes | No | |
| Basic results | 18/10/2017 | 01/11/2017 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN59927814_BasicResults_18Oct17.pdf
- Uploaded 01/11/2017
Editorial Notes
01/11/2017: The basic results of this trial have been uploaded as an additional file.
19/10/2017: The overall trial end date was changed from 01/04/2011 to 01/09/2012.
22/12/2015: Publication reference added.
