Weekly Vitamin D in Pediatric IBD

Sponsor

Emory University (Other)

Overall Status

Completed

CT.gov ID

NCT02076750

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases Skin Pigmentation	Dietary Supplement: Vitamin D3 (cholecalciferol)	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Dietary Supplement: Vitamin D3 (cholecalciferol)
Active Comparator: 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.	Dietary Supplement: Vitamin D3 (cholecalciferol)

Arm

Intervention/Treatment

Experimental: 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.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Active Comparator: 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.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Outcome Measures

Primary Outcome Measures

Change from baseline serum 25-OH vitamin D level at 8 and 12 weeks [Weeks 0, 8 and 12 of study.]

Secondary Outcome Measures

Change from baseline serum calcium level at 8 and 12 weeks [Weeks 0, 8 and 12 of study.]
Change from baseline serum parathyroid hormone level at 8 and 12 weeks [Weeks 0, 8 and 12 of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Healthcare of Atlanta, Egleston Children's Hospital	Atlanta	Georgia	United States	30322
2	Emory Children's Center	Atlanta	Georgia	United States	30322