Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

Not Applicable

Completed

• Conditions: Ulcerative Colitis (UC); Crohn's Disease (CD)
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT01877577
• Lead Sponsor: University of California, San Francisco

Brief Summary

This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.

Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.

Detailed Description

The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.

However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-06-11
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-13
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-01
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
• 18 years of age or older
• 25(OH)D levels <30ng/ml
• willing to give informed written consent

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Exclusion Criteria

• Age < 18 years
• Women who are pregnant or planning to become pregnant
• Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2000 I/U Vitamin D3	Vitamin D3	2000 I/U Vitamin D3 Daily
4000 I/U Vitamin D3	Vitamin D3	4000 I/U Vitamin D3 Daily

Primary Outcome Measures

Name	Time	Method
vitamin D3 supplementation in IBD patients with hypovitaminosis D.	90 days after patient taking the Vitamin D3 supplement daily	To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.

Secondary Outcome Measures

Name	Time	Method
vitamin D3 supplementation on disease activity and quality of life	90 days after patient taking the Vitamin D3 supplement daily	To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D.

Trial Locations

Locations (1)

Community Regional Medical Center, Ambulatory Care Center; 🇺🇸 Fresno, California, United States