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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.

Conditions
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Crohn's Disease (CD), Ulcerative Colitis (UC)

Intervention / Treatment
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* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2000 I/U Vitamin D3<br>2000 I/U Vitamin D3 Daily | Dietary Supplement: Vitamin D3<br>* Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study.<br>* Other names: vitamin D3 cholecalciferol;|
| Active Comparator: 4000 I/U Vitamin D3<br>4000 I/U Vitamin D3 Daily | Dietary Supplement: Vitamin D3<br>* Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study.<br>* Other names: vitamin D3 cholecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D3 supplementation in IBD patients with hypovitaminosis D. | To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D. | 90 days after patient taking the Vitamin D3 supplement daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vitamin D3 supplementation on disease activity and quality of life | To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D. | 90 days after patient taking the Vitamin D3 supplement daily |