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Digestive Diseases and Sciences

, Volume 62, Issue 2, pp 448–455 | Cite as

Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn’s Disease in Remission: A Pilot Randomized Double-Blind Controlled Study

  • Neeraj Narula
  • Mohan Cooray
  • Rebecca Anglin
  • Zack Muqtadir
  • Alisha Narula
  • John K. Marshall
Original Article

Abstract

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.

Clinicaltrials.gov registration no

NCT02615288.

Keywords

Crohn’s disease Ulcerative colitis Inflammatory bowel disease Vitamin D 

Notes

Acknowledgments

This work was funded by a grant obtained from the Canadian Association of Gastroenterology. Vitamin supplements and placebo tablets were provided in kind by Jamieson Laboratories Ltd. Neither the Canadian Association of Gastroenterology nor Jamieson Laboratories Ltd. provided input into study design, data analysis, or the writing of the manuscript.

Author contributions

NN participated in study design, data analysis, data interpretation, manuscript writing; MC contributed to data collection; RA participated in study design, data analysis, manuscript writing; ZM contributed to data collection; AN took part in data collection; JKM participated in study design, data analysis, data interpretation, manuscript writing.

Compliance with ethical standards

Conflict of interest

No authors have any financial interests or connections, direct or indirect, that might raise the question of bias in the work reported in this manuscript.

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Copyright information

© Springer Science+Business Media New York 2016

Authors and Affiliations

  1. 1.Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research InstituteMcMaster UniversityHamiltonCanada

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