Clinical trial NCT02615288: High Dose Vitamin D3 in Crohn's Disease
Official title: Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Keywords: Vitamin D
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Association of Gastroenterology
First posted: 2015-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.

Detailed description: In patients with Crohn's disease in remission, the investigators hypothesized higher doses of vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be tolerated well without side effects of hypercalcemia. The investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety symptoms. In order to determine if there is benefit from high-dose vitamin D3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin D3 at 10,000 IU daily to 1000 IU daily.

Eligibility criteria: Inclusion Criteria:

* a prior diagnosis of Crohn's disease in clinical remission for at least 28 days with a Harvey-Bradshaw index less than or equal to 4
* All maintenance therapies for Crohn's disease will be required to be at stable dose for at least 3 months before randomization, with no systemic steroid therapy within 4 weeks.
* Vitamin D supplements will be discontinued at least 6 weeks before randomization.

Exclusion Criteria:

* Women of child bearing potential who are considering pregnancy during the study period, currently pregnant, or unwilling to use contraception to avoid pregnancy
* Participants with renal insufficiency (serum creatinine greater than 150 umol/L), sarcoidosis, hyperparathyroidism, malignancy, or any other disorder that may lead to hypercalcemia
* Patients with short-gut syndrome or a serum albumin less than 32 g/L
* Concomitant therapy with thiazide diuretics, barbiturates, digitalis, or supplemental products containing vitamin D

Primary outcomes:
measure: Improvement in 25-OH vitamin D level
timeFrame: One year
Secondary outcomes:
measure: Clinical Remission (defined as Harvey-Bradshaw index <=4)
timeFrame: One year
measure: Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))
timeFrame: One year
measure: Improvement in C-reactive protein
timeFrame: One year
measure: Adverse events
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
citation: Narula N, Cooray M, Anglin R, Muqtadir Z, Narula A, Marshall JK. 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.