Vitamin D Supplementation in Crohn's Patients

NCT00742781 | Completed Phase 1 Results

• 1 other identifier: CTSA-PPA-1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Inflammatory Bowel Disease

Keywords

Crohn's; vitamin D

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 25(OH)D3 Serum Levels

  25(OH)D3 levels before and after vitamin D supplementation.

  6 months

Secondary Outcomes (1)

• Health Improvement

  6 months

Study Arms (1)

Dietary supplement

EXPERIMENTAL

Dietary supplement of vitamin D

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Oral supplementation daily with up to 5000 IU over 6 months.

Also known as: Cholecalciferol

Dietary supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (2)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Limitations and Caveats

The main limitation of the study was the lack of placebo control and the small size of the study.

Results Point of Contact

• Title: Dr. Margherita Cantorna
• Organization: Pennsylvania State University

mxc69@psu.edu

814-863-2819

Study Officials

• Margherita T Cantorna, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: May 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 26, 2013
• Results First Posted: July 1, 2013

Record last verified: 2013-07

Locations

US (2)