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

NCT ID: NCT04331639

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

Inclusion Criteria

• Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis
• Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks
• Age 5-25 years old, at study entry
• Measured serum level of 25-OHD of less than 40 ng/mL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD

Exclusion Criteria

• History of any underlying kidney disease
• History of preexisting liver disease
• History of granulomatous disease
• Inability to take oral vitamin D3 as a pill
• History of hypercalcemia or hypercalciuria
• Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Gordon

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Gordon, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rebecca Gordon, MD

Role: CONTACT

rebecca.gordon@childrens.harvard.edu

617-355-7476

Facility Contacts

Rebecca Gordon, MD

Role: primary

Other Identifiers

P00033424

Identifier Type: -

Identifier Source: org_study_id