Recruiting

Vitamin D

Sponsor:

Boston Children's Hospital

Code:

NCT04331639

Conditions

Inflammatory Bowel Disease

Crohn Disease

Ulcerative Colitis

Vitamin D Deficiency

Eligibility Criteria

Sex: All

Age: 5 - 25

Healthy Volunteers: Not accepted

Interventions

vitamin D3

Study Details

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.

Conditions

Inflammatory Bowel Disease

Crohn Disease

Ulcerative Colitis

Vitamin D Deficiency

Study ID

NCT04331639

Start date

Nov 1, 2020

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Sep 1, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • vitamin D target [ Time Frame: at study conclusion, up to 64 weeks ]

Central Contacts and Locations

Central contacts

Rebecca Gordon, MD

617-355-7476rebecca.gordon@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 3, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-03-03.