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Vitamin D Supplementation in Crohn's Patients (CTSA)

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Bowel Disease focused on measuring Crohn's, vitamin D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18-70 years of age with mild to moderate Crohn's disease who are not on active steroid treatment and who do not have ostomies.

Exclusion Criteria:

  • Patients with ulcerative colitis or other bowel conditions which are not Crohn's.
  • Patients with ostomies.
  • Those currently using supplemental vitamin D in excess of the amount in one multivitamin per day.
  • Regular tanning bed users.
  • Persons who report more than moderate alcohol consumption ( > 1 drink/day for women > 2 for men).
  • Pregnant or lactating women or women planning a pregnancy during the study time frame.
  • Regular users of medications which may interfere with assessment of study outcomes .
  • Those who cannot understand written or spoken English .
  • Individuals under medical psychiatric care.

Sites / Locations

  • Milton S. Hershey Medical Center
  • Pennsylvania State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary supplement

Arm Description

Dietary supplement of vitamin D

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index
Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.
25(OH)D3 Serum Levels
25(OH)D3 levels before and after vitamin D supplementation.

Secondary Outcome Measures

Health Improvement
International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.

Full Information

First Posted
August 26, 2008
Last Updated
July 8, 2013
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT00742781
Brief Title
Vitamin D Supplementation in Crohn's Patients
Acronym
CTSA
Official Title
Vitamin D and Crohn's Disease" From the Bench to the Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's disease patients. Patients will be evaluated for increases in circulating vitamin D levels and effects on health benefits including improved bone markers, Crohn's disease activity scores, and inflammatory markers.
Detailed Description
The incidence of autoimmune diseases like inflammatory bowel disease (IBD) has increased in developed countries over the last 50 years. We propose that decreased outdoor activity and increased pollution and diets that lack adequate vitamin D have combined to create large fluctuations in vitamin D status in developed countries and especially in populations that experience winter. Experimentally we've shown that changes in vitamin D status results in more severe forms of experimental IBD. In addition, active vitamin D (1,25(OH)2D3) completely blocks the development of experimental IBD. The vitamin D hypothesis proposes that vitamin D regulates the development and function of the immune system and that changes in vitamin D status affect the development of the resultant immune response and the development of diseases like IBD. Our hypothesis is that because of low dietary vitamin D intakes and malabsorption of many nutrients, Crohn's patients will have low circulating vitamin D levels that are detrimental for their health. We plan to give Crohn's patients 1000 IU of vitamin D/d and determine whether this dose is well tolerated, induces an increase in circulating vitamin D levels and has any additional health benefits (improved bone markers, Crohn's disease activity scores, inflammatory markers).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Crohn's, vitamin D

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement
Arm Type
Experimental
Arm Description
Dietary supplement of vitamin D
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Oral supplementation daily with up to 5000 IU over 6 months.
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Description
Questionnaire and physical measurements combine to generate a score. Scores below 150 indicate remission, 150-350 mild to moderate disease, over 350 severe disease. The total range of scores are from 0- Don't have Crohn's disease to 600 severe Crohn's disease. 0-150 is remission, 151-219 is mild, 220-450 is moderate disease and over 451 is severe.
Time Frame
6 months
Title
25(OH)D3 Serum Levels
Description
25(OH)D3 levels before and after vitamin D supplementation.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health Improvement
Description
International Physical Activity Questionnaire. Minutes/week for 30 min/day, 5days (MET) are calculated for different activity intensities. Total range of scores 0-600 MET low activity, 600-1200 Moderate activity, Over 1200-3000 High activity.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients 18-70 years of age with mild to moderate Crohn's disease who are not on active steroid treatment and who do not have ostomies. Exclusion Criteria: Patients with ulcerative colitis or other bowel conditions which are not Crohn's. Patients with ostomies. Those currently using supplemental vitamin D in excess of the amount in one multivitamin per day. Regular tanning bed users. Persons who report more than moderate alcohol consumption ( > 1 drink/day for women > 2 for men). Pregnant or lactating women or women planning a pregnancy during the study time frame. Regular users of medications which may interfere with assessment of study outcomes . Those who cannot understand written or spoken English . Individuals under medical psychiatric care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margherita T Cantorna, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

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Vitamin D Supplementation in Crohn's Patients

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