Vitamin D in CKD - Vascular Function, Structure and Immune Regulation
Research type
Research Study
Full title
Impact of Vitamin D Supplementation on Vascular Function, Vascular Structure and Immune Regulation in Patients with Chronic Kidney Disease and Low Vitamin D Levels – A Pilot Randomised Trial.
IRAS ID
189815
Contact name
Debasish Banerjee
Contact email
Sponsor organisation
St George's University, London
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Chronic kidney disease (CKD) is a major public health problem, involving about 10% of the population and consumes significant healthcare resources due to associated cardiovascular events, largely heart attack and strokes. Traditional risk factor management like cholesterol control has been largely ineffective and focus is turning to non-traditional risk factors such as vitamin D deficiency. Vitamin D deficiency is common in CKD patients, and associated with increased cardiovascular events and deaths in both CKD patients and general population. Studies are urgently necessary to explore the impact of this cheap and accessible vitamin on cardiovascular disease.
Early signs of cardiovascular disease can be detected using ultrasound scans of the blood vessels in the arm and neck (“flow mediated dilatation of the brachial artery” and “carotid intima media thickness”). These ultrasound changes predict the progression of cardiovascular disease and are present in patients with CKD and low vitamin D levels. In addition, experimental studies have also shown an emerging role of vitamin D on the immune system, which in turn, may influence the development of vessel disease. A certain subtype of white blood cells (CD4+CD28null T lymphocytes) can be measured in the blood, and are increased in numbers in patients with cardiovascular disease, and in CKD have been shown to be associated with vitamin D deficiency.
In this pilot randomised study we will test the methodology, train investigators and provide data on expected change to inform future trials. We aim to demonstrate the impact of Vitamin D supplementation over 26 weeks versus no supplementation in patients with stable moderate-severe CKD and low vitamin D levels on
• Vessel function (flow mediated dilatation of the brachial artery)
• Vessel structure (carotid intima media thickness)
• Number of CD4+CD28null T lymphocytes (a subtype of white blood cells implicated in cardiovascular disease).REC name
London - Surrey Research Ethics Committee
REC reference
15/LO/2063
Date of REC Opinion
18 Dec 2015
REC opinion
Further Information Favourable Opinion