The Effects of colecalciferol supplementation on urine calcium.
Research type
Research Study
Full title
The Effects of colecalciferol supplementation on urine calcium and body composition in patients with spinal cord injury: A randomised controlled trial. A pilot study.
IRAS ID
166802
Contact name
Irina Gainullina
Contact email
Sponsor organisation
Buckinghamshire Healthcare NHS Trust
Duration of Study in the UK
0 years, 12 months, 0 days
Research summary
Vitamin D, often called “the sunshine vitamin”, is a hormone which our bodies make in response to sun exposure. However for vulnerable groups, like patients with spinal cord injury (SCI), sunlight can be an unreliable source of vitamin D. A recent observational study conducted in the National Spinal Injuries Centre found 67.8% of SCI patients were vitamin D deficient. This growing concern has led the UK Chief Medical Officer to restate Government advice on supplementing the diets in vulnerable groups of vitamin D supplement containing 10 microgram per day. However, SCI centre’s health professionals are concerned that these recommendations will increase the risk of developing calcinosis and renal calculi.
Research questions: Does a daily prescription of vitamin D and calcium supplementation has an effect on urine-calcium excretion (a risk factor for renal calculi)? How can we use this to better understand the effect of vitamin D supplementation on body composition?
The purpose of this trial is to (1) assess the effect of vitamin D (800 IU, 20 mcg) and supplemental calcium (1200 mg) for 60 days compared to vitamin D without calcium for the change in urinary calcium; (2) analyse the effect of vitamin D with calcium and vitamin D without calcium supplementation in optimising serum vitamin D concentration and; (3)their effect on body composition (body muscle and fat) by bioelectrical impedance/Dual energy X-ray absorptiometry (DEXA) and; (4) to assess the dietary intake of vitamin D and calcium in SCI patients with vitamin D deficiency (serum vitamin D between 25-50nmol/L) .
Study design: Randomised controlled trial. Pilot study. Sample size: 60.We are randomising vitamin D deficient participants to receive daily vitamin D / calcium supplement and vitamin D in one of two experimental groups:
Group1:800 iu (20 microgram) vitamin D3 (i.e colecalciferol) and supplemental calcium (1200 mg) for 2 months.
Group 2: 800 iu (20 microgram) vitamin D3 (i.e colecalciferol) without supplemental calcium for the same length of time.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1428
Date of REC Opinion
18 Dec 2014
REC opinion
Unfavourable Opinion