Phase 1
N=21
Vitamin D Supplementation in Crohn's Patients
Inflammatory Bowel Disease
Bottom Line
View on ClinicalTrials.gov: NCT00742781 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Crohn's Disease Activity Index — 230; 112 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penn State University
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crohn's Disease Activity Index |
230; 112 | — |
| PRIMARY 25(OH)D3 Serum Levels |
16; 45 | — |
| SECONDARY Health Improvement |
5778; 6714 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00742781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.