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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease (CD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Community Regional Medical Center, Ambulatory Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

2000 I/U Vitamin D3

4000 I/U Vitamin D3

Arm Description

2000 I/U Vitamin D3 Daily

4000 I/U Vitamin D3 Daily

Outcomes

Primary Outcome Measures

vitamin D3 supplementation in IBD patients with hypovitaminosis D.
To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.

Secondary Outcome Measures

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.

Full Information

First Posted
June 11, 2013
Last Updated
July 1, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01877577
Brief Title
Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D
Official Title
Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease (CD), Ulcerative Colitis (UC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2000 I/U Vitamin D3
Arm Type
Active Comparator
Arm Description
2000 I/U Vitamin D3 Daily
Arm Title
4000 I/U Vitamin D3
Arm Type
Active Comparator
Arm Description
4000 I/U Vitamin D3 Daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
vitamin D3 cholecalciferol
Intervention Description
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.
Primary Outcome Measure Information:
Title
vitamin D3 supplementation in IBD patients with hypovitaminosis D.
Description
To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D.
Time Frame
90 days after patient taking the Vitamin D3 supplement daily
Secondary Outcome Measure Information:
Title
vitamin D3 supplementation on disease activity and quality of life
Description
To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D.
Time Frame
90 days after patient taking the Vitamin D3 supplement daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Limsui, MD
Organizational Affiliation
Assistant Clinical Professor, UCSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Medical Center, Ambulatory Care Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21677747
Citation
Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209.
Results Reference
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PubMed Identifier
21527593
Citation
Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267.
Results Reference
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PubMed Identifier
17962355
Citation
Kong J, Zhang Z, Musch MW, Ning G, Sun J, Hart J, Bissonnette M, Li YC. Novel role of the vitamin D receptor in maintaining the integrity of the intestinal mucosal barrier. Am J Physiol Gastrointest Liver Physiol. 2008 Jan;294(1):G208-16. doi: 10.1152/ajpgi.00398.2007. Epub 2007 Oct 25.
Results Reference
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PubMed Identifier
21118827
Citation
Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29.
Results Reference
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Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D

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