Weekly Vitamin D in Pediatric IBD

Inflammatory Bowel Diseases Clinical Trial

Official title:

Weekly Vitamin D3 for Treatment of Hypovitaminosis D in Children and Adolescents With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076750
• Other study ID #: IRB00061627
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 11, 2013
• Last updated: November 25, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Emory University Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

Inclusion Criteria:

1. Established diagnosis of inflammatory bowel disease made by a pediatric gastroenterologist and confirmed by histopathology

2. Serum 25-OH vitamin D level <30 ng/mL at time of enrollment.

3. Age 8-21 years

4. Weight > 20 kg

5. Parent, guardian, or subject (where applicable) able to give consent/assent

Exclusion Criteria:

1. Inability to ingest oral vitamin D3 capsules

2. Presence of known hepatobiliary disease

3. Presence of known kidney disease or history of renal stones

4. Use of systemic steroids within 60 days prior to enrollment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Skin Pigmentation

Intervention

Dietary Supplement:
• Vitamin D3 (cholecalciferol)

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta, Egleston Children's Hospital	Atlanta	Georgia
United States	Emory Children's Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Osunkwo I, Ziegler TR, Alvarez J, McCracken C, Cherry K, Osunkwo CE, Ofori-Acquah SF, Ghosh S, Ogunbobode A, Rhodes J, Eckman JR, Dampier C, Tangpricha V. High dose vitamin D therapy for chronic pain in children and adolescents with sickle cell disease: results of a randomized double blind pilot study. Br J Haematol. 2012 Oct;159(2):211-5. doi: 10.1111/bjh.12019. Epub 2012 Aug 28. — View Citation

Pappa H, Thayu M, Sylvester F, Leonard M, Zemel B, Gordon C. Skeletal health of children and adolescents with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2011 Jul;53(1):11-25. doi: 10.1097/MPG.0b013e31821988a3. Erratum in: J Pediatr Gastroenterol Nutr. 2012 Apr;54(4):571. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks		Weeks 0, 8 and 12 of study.	No
Secondary	Change from baseline serum calcium level at 8 and 12 weeks		Weeks 0, 8 and 12 of study.	Yes
Secondary	Change from baseline serum parathyroid hormone level at 8 and 12 weeks		Weeks 0, 8 and 12 of study	Yes