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

July 1, 2014 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93721
        • Community Regional Medical Center, Ambulatory Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2000 I/U Vitamin D3
2000 I/U Vitamin D3 Daily
Dietary supplement: Vitamin D3
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.
Other Names:
  • vitamin D3 cholecalciferol
ACTIVE_COMPARATOR: 4000 I/U Vitamin D3
4000 I/U Vitamin D3 Daily
Dietary supplement: Vitamin D3
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.
Other Names:
  • vitamin D3 cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vitamin D3 supplementation in IBD patients with hypovitaminosis D.
Time Frame: 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.
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
Time Frame: 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.
90 days after patient taking the Vitamin D3 supplement daily

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: David Limsui, MD, Assistant Clinical Professor, UCSF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

June 11, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (ESTIMATE)

June 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBDVitD-42012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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