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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Intervention / Treatment: Dietary supplement: vitamin D3

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rebecca Gordon, MD; Phone Number: 617-355-7476; Email: rebecca.gordon@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Rebecca Gordon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vitamin D target	assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL	at study conclusion, up to 64 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in vitamin D level	assess change in serum 25-OHD level from study entry to study conclusion	at study conclusion, up to 64 weeks
vitamin D binding protein	assessing vitamin D binding protein and free vitamin D	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
parathyroid hormone	assessing parathyroid hormone	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
serum safety parameter	evaluate serum calcium level	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
urine safety parameter	evaluate urinary calcium to creatinine ratio	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
bone mineral density	assess changes in bone density and body composition as assessed by DXA scan, when clinically available	at study conclusion, up to 64 weeks, when clinically available
markers of bone turnover	evaluating bone turnover markers such as c-telopeptide, bone specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen. May do some of these, and then depending upon the results, consider doing additional analytes, as exploratory analysis.	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
inflammatory bowel disease treatment parameters	assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available	at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
cytokine measurements	evaluating pro-inflammatory and anti-inflammatory cytokine levels, specifically interleukin-17 and interferon gamma, with likely additional exploratory studies to further characterize immune response to vitamin D repletion depending upon these results.	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
c-reactive protein	evaluating c-reactive protein	at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
erythrocyte sedimentation rate	evaluating erythrocyte sedimentation rate	at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
health-related quality of life questionnaire for inflammatory bowel disease	assess quality of life measures in children with inflammatory bowel disease	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
baseline questionnaire on overall health	assess overall health questionnaire	at 0 weeks (entry into study)
fracture history questionnaire	assess fracture history	at 0 weeks (entry into study)
food frequency questionnaire	assess calcium and vitamin D food frequency	at 0 weeks (entry into study)
physical activity questionnaire	assess physical activity level	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
sun exposure questionnaire	assess sunlight exposure	at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
follow-up questionnaire on overall health	assess for any changes in inflammatory bowel disease treatment since last visit	at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Rebecca Gordon, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Vitamin D Deficiency; Crohn Disease; Intestinal Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: P00033424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No