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Crohn's Disease relapse rate of 3 in 8 with 1,000 IU vs 0 in 12 with 10,000 IU of Vitamin D – RCT Feb 2017

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.

AIM:
To assess the tolerability and efficacy of high-dose vitamin D3 in patients with Crohn's disease (CD).

METHODS:
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.

RESULTS:
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.

CONCLUSIONS:
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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