NCT04331639

High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy

Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

Detailed description

The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.

Conditions

• Inflammatory Bowel Disease
• Crohn Disease
• Ulcerative Colitis
• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	vitamin D3	Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.

Timeline

• Start date: 2020-11-01
• Primary completion: 2024-09-01
• Completion: 2025-12-31
• First posted: 2020-04-02
• Last updated: 2025-03-03

Locations

1 site across 1 country: United States