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

  • STATUS
    Recruiting
  • End date
    Sep 8, 2024
  • participants needed
    50
  • sponsor
    Boston Children's Hospital
Updated on 4 October 2022
infliximab
ulcerative colitis
inflammatory bowel disease
vitamin
vedolizumab
enteropathy
colitis
ulceration
indeterminate colitis

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.

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.

Details
Condition Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
Treatment Vitamin D3
Clinical Study IdentifierNCT04331639
SponsorBoston Children's Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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