CKD, Vitamin D and the microcirculation (Version 1.0)

• Research type

  Research Study

• Full title

  THE EFFECT OF VITAMIN D ON THE MICROCIRCULATION OF PATIENTS WITH CHRONIC KIDNEY DISEASE AND VITAMIN D DEFICIENCY

• IRAS ID

  15090

• Sponsor organisation

  Barts and the London NHS Trust

• Eudract number

  2008-008745-38

• ISRCTN Number

  N/A

• Research summary

  Chronic kidney disease (CKD) is a common, world wide problem which occurs when kidneys become scarred and as a result, operate at a reduced level of function. More patients with CKD die from heart disease and strokes than end up on dialysis treatment and so the focus of kidney specialists is to try and reduce the risk of patients with CKD dying from these conditions.Vitamin D occurs naturally in all of us and is generated in the skin by exposure to sunlight. Very few foods in nature contain vitamin D. Very low levels of vitamin D are common in patients with CKD and this is now understood to cause major health problems. Vitamin D therapy is traditionally given to improve bone health but there is growing evidence that vitamin D treatment has effects on the body beyond the bones and that it may reduce the hardening of the blood vessels seen in CKD which itself is thought to cause the cardiac complications of this condition. Currently, vitamin D treatment in the early stages of CKD is not routine. This study aims to determine if we should be giving vitamin D therapy to patients in the early stages of CKD to reduce the risk of future heart attacks and strokes. The study will also determine how the microscopic blood vessels in the body behave in early CKD, information which can be used to predict future cardiovascular events.We plan to recruit 80 individuals, all with CKD and low levels of vitamin D. Half will be given vitamin D capsules and half will receive a placebo capsule (which has no medical effect). We will study these individuals over a 6 month period and determine if and how vitamin D therapy is beneficial in early CKD.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/9

• Date of REC Opinion

  13 Feb 2009

• REC opinion

  Favourable Opinion