Weekly Vitamin D in Pediatric IBD

NCT ID: NCT02076750

Last Updated: 2014-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-06-30

Brief 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).

Detailed 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.

Conditions

Inflammatory Bowel Diseases; Skin Pigmentation

Keywords

Inflammatory Bowel Diseases; Vitamin D; Cholecalciferol; Skin Pigmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vitamin D3 (cholecalciferol) 10,000 IU per 10 kg body weight

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.

Group Type: EXPERIMENTAL

Vitamin D3 (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol) 5,000 IU per 10 kg body weight

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D3 (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Vitamin D3 (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Subra Kugathasan, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Subra Kugathasan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta, Egleston Children's Hospital

Atlanta, Georgia, United States

Emory Children's Center

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22924607 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21694532 (View on PubMed)

Other Identifiers

IRB00061627

Identifier Type: -

Identifier Source: org_study_id