Skip to content

Weekly Vitamin D in Pediatric IBD

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02076750
Enrollment
34
Registered
2014-03-04
Start date
2013-03-31
Completion date
2014-06-30
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Diseases, Skin Pigmentation

Keywords

Inflammatory Bowel Diseases, Vitamin D, Cholecalciferol, Skin Pigmentation

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3 (cholecalciferol)

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline serum 25-OH vitamin D level at 8 and 12 weeksWeeks 0, 8 and 12 of study.

Secondary

MeasureTime frame
Change from baseline serum calcium level at 8 and 12 weeksWeeks 0, 8 and 12 of study.
Change from baseline serum parathyroid hormone level at 8 and 12 weeksWeeks 0, 8 and 12 of study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026