Investigators

Dr Faisel Khan and Prof. Jill Belch

Institution

Vascular and Inflammatory Diseases Research Unit, The Institute of Cardiovascular Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK

Background and aims

Many ME/CFS patients have associated cardiovascular symptoms, such as reduced heart rate and problems with blood pressure regulation. Recent research at the Institute of Cardiovascular Research, Ninewells Hospital has shown that they also have significantly greater arterial stiffness than healthy people, an important finding since arterial stiffness is recognised to be an important factor in the development of early cardiovascular disease.

The group headed by Dr Faisel Khan at Ninewells Hospital, Dundee has been examining arterial stiffness (as measured by the gold-standard technique of pulse wave velocity) in relation to levels of vitamin D in the blood – and has discovered some evidence of a relationship between lower levels of vitamin D and increased arterial stiffness. The question arises whether vitamin D supplementation might reverse the arterial stiffness, and in addition have positive effects on vascular function, as well as on neuromuscular functioning and chronic pain (two symptoms which are linked with vitamin D deficiency and which are facets of the day-to-day experience of ME/CFS patients). As vitamin D is easy to measure and deficiency is relatively easy to correct with supplementation, Dr Khan’s group planned a clinical trial to test whether vitamin D supplementation in ME/CFS patients can lead to improvements in cardiovascular function and symptoms of ME/CFS.

The researchers have recruited 50 ME/CFS patients from the surrounding areas of Scotland. Participants will come to the unit in Dundee on 5 occasions for a variety of measurements; one half of the participants with be given high-dose vitamin D oil, and one half will be given a matching dummy placebo oil by mouth. Neither the patients nor the investigators will know which oil a person has taken, so that the results of the tests cannot be influenced in any way.

Each patient will have a full medical examination initially, and the outcome measures will be performed at baseline, 2 and 6 months. The primary aim is to see whether giving oral vitamin D supplementation improves arterial stiffness in ME/CFS patients, compared with giving a matching dummy supplement. Secondary outcomes include endothelial function; metabolic, thrombotic and inflammatory markers; and symptoms as assessed by fatigue scales, SF36 quality of life, and HAD scale.

More detailed information on this study can be found at the website of Current Controlled Trials.