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- Title
Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study.
- Authors
Narula, Neeraj; Cooray, Mohan; Anglin, Rebecca; Muqtadir, Zack; Narula, Alisha; Marshall, John; Marshall, John K
- Abstract
<bold>Aim: </bold>To assess the tolerability and efficacy of high-dose vitamin D3 in patients with Crohn's disease (CD).<bold>Methods: </bold>This was a randomized, double-blind placebo-controlled trial of high-dose vitamin D3 at 10,000 IU daily (n = 18) compared to 1000 IU daily (n = 16) for 12 months in patients with CD in remission. The primary outcome was change in serum 25-hydroxy-vitamin D levels. Secondary outcomes included clinical relapse rates and changes in mood scores.<bold>Results: </bold>High-dose vitamin D3 at 10,000 IU daily significantly improved 25-hydroxy-vitamin D levels from a mean of 73.5 nmol/L [standard deviation (SD) 11.7 nmol/L] to 160.8 nmol/L (SD 43.2 nmol/L) (p = 0.02). On an intention-to-treat basis, the rate of relapse was not significantly different between patients receiving low- and high-dose vitamin D3 (68.8 vs 33.3%, p = 0.0844). In per-protocol analysis, clinical relapse of Crohn's disease was less frequently observed in patients receiving a high dose (0/12 or 0%) compared to those receiving a low dose of 1000 IU daily (3/8 or 37.5%) (p = 0.049). Improvement in anxiety and depression scores and a good safety profile were observed in both groups treated with vitamin D3.<bold>Conclusions: </bold>Oral supplementation with high-dose vitamin D3 at 10,000 IU daily significantly improved serum 25-hydroxy-vitamin D levels. Rates of clinical relapse were similar between both groups. Larger studies using high-dose vitamin D3 for treatment of inflammatory bowel diseases are warranted. CLINICALTRIALS.<bold>Gov Registration No: </bold>NCT02615288.
- Subjects
CHOLECALCIFEROL; CROHN'S disease; DIETARY supplements; PATIENT readmissions; RANDOMIZED controlled trials; PATIENTS; THERAPEUTICS; AFFECT (Psychology); COMPARATIVE studies; DOSE-effect relationship in pharmacology; RESEARCH methodology; MEDICAL cooperation; RESEARCH; VITAMIN D; VITAMINS; DISEASE relapse; PILOT projects; EVALUATION research; BLIND experiment; PSYCHOLOGY
- Publication
Digestive Diseases & Sciences, 2017, Vol 62, Issue 2, p448
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-016-4396-7