Vitamin D Supplementation in Crohn's Patients (CTSA)
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|ClinicalTrials.gov Identifier: NCT00742781|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : July 1, 2013
Last Update Posted : July 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease||Dietary Supplement: Vitamin D||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Vitamin D and Crohn's Disease" From the Bench to the Clinic|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
Experimental: Dietary supplement
Dietary supplement of vitamin D
Dietary Supplement: Vitamin D
Oral supplementation daily with up to 5000 IU over 6 months.
Other Name: Cholecalciferol
- Crohn's Disease Activity Index [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]25(OH)D3 levels before and after vitamin D supplementation.
- Health Improvement [ Time Frame: 6 months ]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.
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): NCT00742781
|United States, Pennsylvania|
|Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Pennsylvania State University|
|University Park, Pennsylvania, United States, 16802|
|Principal Investigator:||Margherita T Cantorna, PhD||Penn State University|