Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study.
Dig Dis Sci. 2017 Feb;62(2):448-455. doi: 10.1007/s10620-016-4396-7. Epub 2016 Dec 14.
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Narula N1, Cooray M2, Anglin R2, Muqtadir Z2, Narula A2, Marshall JK2.
- 1 Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada. Neeraj.narula at medportal.ca.
- 2 Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, 1280 Main Street West, Unit 3V28, Hamilton, ON, L8S 4K1, Canada.
To assess the tolerability and efficacy of high-dose vitamin D3 in patients with Crohn's disease (CD).
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.
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.
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.
GOV REGISTRATION NO: NCT02615288.
PMID: 27975236 DOI: 10.1007/s10620-016-4396-7
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