High Dose Vitamin D3 in Crohn's Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose Vitamin D3 (10,000 IU daily)<br> | Dietary Supplement: Vitamin D3<br> <br> |
| Placebo Comparator: Low Dose Vitamin D3 (1000 IU daily)<br> | Dietary Supplement: Vitamin D3<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in 25-OH vitamin D level |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission (defined as Harvey-Bradshaw index <=4) | Number of patients who maintain clinical remission | One year | 
| 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 | 
| Improvement in C-reactive protein | Comparison of C-reactive protein levels in high and low dose vitamin D3 groups | One year | 
| Adverse events | Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D