RECRUITING

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

Conditions

Inflammatory Bowel Disease Crohn Disease Ulcerative Colitis Vitamin D Deficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-01

Study Completion:2024-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04331639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Rebecca Gordon, MD

CONTACT

617-355-7476

rebecca.gordon@childrens.harvard.edu

Principal Investigator

Rebecca Gordon, MD

PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Rebecca Gordon, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-01

Study Completion Date2024-09

Study Record Updates

Study Start Date2020-11-01

Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

Inflammatory Bowel Disease
Crohn Disease
Ulcerative Colitis
Vitamin D Deficiency