21 November 2011
Researchers from Dundee University are looking for a further 15 volunteers with M.E./CFS to take part in a clinical trial which will look at the effects of oral vitamin D supplementation on cardiovascular disease risk in patients with M.E./CFS.
The study will involve 50 participants but most have already been recruited.
Participants must be well enough to attend five visits to the clinical trial in Dundee and you cannot take part if you are pregnant or trying for a baby.
Background
The research team say, “Many M.E./CFS patients can have problems with the cardiovascular system such as poor blood pressure regulation and heart rate control. The elasticity of the arteries, also referred to as arterial stiffness is an important factor that regulates how blood vessels work. Arterial stiffness is higher in M.E./CFS patients compared with people who do not have the condition.
“We have previously found that the degree of increased arterial stiffness in M.E./CFS patients might be affected by vitamin D levels. We found that higher levels of vitamin D were associated with better blood vessel function in M.E./CFS patients, but we cannot be sure whether there is a direct relationship between vitamin D levels and blood vessel function. We do not know at present whether vitamin D causes arterial stiffness or any of the symptoms of CFS.
“Therefore, to help us better understand whether there might be a more direct link between vitamin D levels and blood vessel function, we are planning in the repent study to see whether giving oral vitamin D supplementation improves arterial stiffness in M.E./CFS patients and to compare this to a matching dummy supplement.”
What is involved?
The information leaflet for participants says:
The first and fourth visit will last 15 minutes, and the other three will last about two hours each.
Visit 1 will be a screening visit.
If suitable, you will be asked to attend for visit 2 (baseline investigation) which will be arranged between 1 and 3 weeks after your screening visit. Subsequent visits (3 to 5) will be arranged at eight week intervals.
What happens at each visit?
If you decide to take part, we will ask you to fast and refrain from smoking for at least two hours before each visit.
At your first visit we will go through the informed consent form with you, sign the informed consent form, and take a small blood sample from a vein in your arm. We will use this to measure the vitamin D level in your blood and the function of your liver to make sure you can safely take vitamin D.
Based on the result of your screening blood tests we will see if you qualify for the study. We will then invite you to come for the baseline investigation (visit 2) and dosing visit (month 0). At this visit we will ask you to complete a set of questionnaires on fatigue, quality of life and emotional adjustment which will be repeated at visit 5 again.
If you are not suitable to participate in the study, we will contact you and let you know this. In case where screening reveals a finding requiring medical intervention or investigation, Dr. Kabir (Clinical Research Fellow) will discuss this with you and with your permission, liaise with your GP for further appropriate action to be taken.
At visits 2, 3 & 5, we will take a small sample of blood (the equivalent of about two tablespoons) from a vein in your arm. With your permission, we will store a tube of your blood sample for future study. We will also perform three non-invasive tests of blood vessel function, as detailed below, none of which involve the use of needles.
At visit 2, 3 & 4 we will also ask you to take 5 ml (about a teaspoon) of vitamin D oil or matching dummy placebo oil by mouth. Neither you nor the investigators will know which oil you have taken, so that the results of the tests cannot be influenced in any way. The allocation of vitamin D or matching dummy will be done according to prior randomisation.
Blood vessel tests
Arterial stiffness: blood pressure will be measured 3 times using an automated blood pressure monitor. A pen-like probe will be used to record your pulse of wrist, upper thigh and neck. At the same time, the electrical activity of your heart will be monitored using an ECG machine. Additionally, the elasticity of the blood vessels in your neck will be measured by using an ultrasound probe placed over the blood vessel.
Flow-mediated dilatation: we will look at a blood vessel in your arm (the brachial artery) using an ultrasound scanner. The function of this artery will be assessed by measuring its diameter before and after occluding it with a blood pressure cuff for 5 minutes. Occluding the artery can cause some mild discomfort (like when you have fallen asleep on your arm), but that should be the only discomfort. The diameter of the artery will again be measured before and 5 minutes after a spray of Glyceryl Trinitrate is given under the tongue. Glyceryl Trinitrate is a medicine that is normally used in the treatment of angina, and can cause a mild headache. Throughout these measurements, the electrical activity of your heart will be monitored using an ECG machine.
Further information
The study is funded by funded by ME Research UK.
Further information (including contraception implications, confidentiality, expenses and insurance issues) is available in the trial’s information leaflet for prospective participants.
If you are interested in joining the trial and/or have further questions please contact:
Dr Faisel Khan, Principal Investigator
Dr Golam Kabir, Clinical Research Fellow - Tel: 01382 660111 Ext: 33123; Bleep: 4100
Ms Fiona Adams, Research Technician
