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

Last updated: February 27, 2025
Sponsor: Boston Children's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Crohn's Disease (Pediatric)

Treatment

vitamin D3

Clinical Study ID

NCT04331639
P00033424
  • Ages 5-25
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, andindeterminate 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 nochanges in vitamin D supplementation in the interim. Of note, 25-OHD levels areevaluated routinely as part of standard clinical care for IBD

Exclusion

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

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: vitamin D3
Phase:
Study Start date:
November 01, 2020
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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