Clinical trial NCT00742781: Vitamin D Supplementation in Crohn's Patients
Official title: Vitamin D and Crohn's Disease" From the Bench to the Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammatory Bowel Disease
Keywords: Crohn's
vitamin D
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Crohn's Disease Activity Index
timeFrame: 6 months
measure: 25(OH)D3 Serum Levels
timeFrame: 6 months
Secondary outcomes:
measure: Health Improvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: University Park
country: United States
facility: Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Margherita T Cantorna, PhD
role: PRINCIPAL_INVESTIGATOR
References: