High Dose Vitamin D3 in Crohn's Disease

Not Applicable

Completed

• Conditions: Crohn's Disease
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT02615288
• Lead Sponsor: McMaster University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-03
• Status Verified: 2015-11
• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-24
• Last Update Submitted: 2015-11-24
• Study First Posted: 2015-11-26
• Last Update Posted: 2015-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Vitamin D3 (10,000 IU daily)	Vitamin D3	-
Low Dose Vitamin D3 (1000 IU daily)	Vitamin D3	-

Primary Outcome Measures

Name	Time	Method
Improvement in 25-OH vitamin D level	One year

Secondary Outcome Measures

Name	Time	Method
Clinical Remission (defined as Harvey-Bradshaw index <=4)	One year	Number of patients who maintain clinical remission
Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))	One year	Number of patients who achieve significant improvement in HADS (reduction of 2 or more)
Adverse events	One year	Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events
Improvement in C-reactive protein	One year	Comparison of C-reactive protein levels in high and low dose vitamin D3 groups