A Phase 1/2 interventional study of Vitamin D3 (cholecalciferol) in Inflammatory Bowel Diseases and Skin Pigmentation, sponsored by Emory University. Completed at 2 sites in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2014-11-26.
Sponsored by Emory University · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is effective in correcting low vitamin D levels in children and adolescents with inflammatory bowel disease (also known as Crohn's disease and ulcerative colitis).
The role of vitamin D in skeletal health is well established. More recently, vitamin D has been implicated in multiple other disease states and is currently a topic of much discussion in the pediatric and adult medical literature. Individuals with gastrointestinal or hepatobiliary diseases that limit the absorption of dietary vitamin D and those individuals with limited sunlight exposure or darker skin color are at risk for suboptimal vitamin D status. Recent joint guidelines from the North American and European Societies of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN, respectively) have recommended routine surveillance and treatment for vitamin D insufficiency/deficiency in children affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and ulcerative colitis (UC). Current recommendations are for prolonged daily dosing of oral vitamin D, but studies in children with other chronic diseases have demonstrated the benefit of improved compliance with less frequent, higher doses of vitamin D. The primary goal of this pilot study is to establish whether weekly dosing of vitamin D can correct suboptimal vitamin D status in children with inflammatory bowel disease. A secondary goal is to evaluate whether pediatric IBD patients with darker skin respond differently to vitamin D therapy than do their lighter-skinned counterparts.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
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Exclusion Criteria:
Vitamin D3 (cholecalciferol) will be administered orally at a dose of 10,000 IU per 10 kg body weight weekly for 6 consecutive weeks. The maximum dose will be 50,000 IU weekly for patients weighing 50 kg or greater.
Dietary Supplement: Vitamin D3 (cholecalciferol)
Vitamin D3 (cholecalciferol) will be administered orally at a dose of 5,000 IU per 10 kg body weight weekly for 6 consecutive weeks. The maximum dose will be 25,000 IU weekly for patients weighing 50 kg or greater.
Dietary Supplement: Vitamin D3 (cholecalciferol)
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks
Time frame: Weeks 0, 8 and 12 of study.
Change from baseline serum calcium level at 8 and 12 weeks
Time frame: Weeks 0, 8 and 12 of study.
Change from baseline serum parathyroid hormone level at 8 and 12 weeks
Time frame: Weeks 0, 8 and 12 of study
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Emory University