Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn’s Disease in Remission: A Pilot Randomized Double-Blind Controlled Study
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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.
Clinicaltrials.gov registration no
KeywordsCrohn’s disease Ulcerative colitis Inflammatory bowel disease Vitamin D
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.
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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