NCT Number: NCT02076750
Weekly Vitamin D in Pediatric IBD
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).
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Notify MeKey information
Conditions
Age range
8 year–21 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Children's Healthcare of Atlanta, Egleston Children's Hospital, Atlanta, Georgia, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology
- Serum 25-OH vitamin D level <30 ng/mL at time of enrollment.
- Age 8-21 years
- Weight > 20 kg
- Parent, guardian, or subject (where applicable) able to give consent/assent
Exclusion criteria
- Inability to ingest oral vitamin D3 capsules
- Presence of known hepatobiliary disease
- Presence of known kidney disease or history of renal stones
- Use of systemic steroids within 60 days prior to enrollment.
Treatment and study plan
Primary outcomes
-
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks
Time frame: Weeks 0, 8 and 12 of study.
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Emory University
Other
Registry information
Official study title
Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Mar 4, 2014
- Registry last updated
- Nov 26, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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