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

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ClinicalTrials.gov Identifier: NCT01877577
Recruitment Status : Completed
First Posted : June 13, 2013
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Crohn's Disease (CD) Ulcerative Colitis (UC) Dietary Supplement: Vitamin D3 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
Study Start Date : April 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013


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 Name: 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 Name: vitamin D3 cholecalciferol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877577


Locations
United States, California
Community Regional Medical Center, Ambulatory Care Center
Fresno, California, United States, 93721
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: David Limsui, MD Assistant Clinical Professor, UCSF

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01877577     History of Changes
Other Study ID Numbers: IBDVitD-42012
First Posted: June 13, 2013    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Vitamin D Deficiency
Vitamins
Vitamin D
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Avitaminosis
Rickets
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents