High Dose Vitamin D3 in Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

Impact of High Dose Vitamin D3 Supplementation in Treatment of Crohn's Disease in Remission: A Randomized Double-blind Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615288
• Other study ID #: 13-038
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 24, 2015
• Start date: January 2014

Study information

• Verified date: November 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• Vitamin D3

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Association of Gastroenterology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in 25-OH vitamin D level		One year	No
Secondary	Clinical Remission (defined as Harvey-Bradshaw index <=4)	Number of patients who maintain clinical remission	One year	No
Secondary	Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))	Number of patients who achieve significant improvement in HADS (reduction of 2 or more)	One year	No
Secondary	Improvement in C-reactive protein	Comparison of C-reactive protein levels in high and low dose vitamin D3 groups	One year	No
Secondary	Adverse events	Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events	One year	Yes