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

Primary Purpose

Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vitamin D3
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's HospitalRecruiting

Outcomes

Primary Outcome Measures

vitamin D target
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL

Secondary Outcome Measures

change in vitamin D level
assess change in serum 25-OHD level from study entry to study conclusion
vitamin D binding protein
assessing vitamin D binding protein and free vitamin D
parathyroid hormone
assessing parathyroid hormone
serum safety parameter
evaluate serum calcium level
urine safety parameter
evaluate urinary calcium to creatinine ratio
bone mineral density
assess changes in bone density and body composition as assessed by DXA scan, 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.
inflammatory bowel disease treatment parameters
assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available
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.
c-reactive protein
evaluating c-reactive protein
erythrocyte sedimentation rate
evaluating erythrocyte sedimentation rate
health-related quality of life questionnaire for inflammatory bowel disease
assess quality of life measures in children with inflammatory bowel disease
baseline questionnaire on overall health
assess overall health questionnaire
fracture history questionnaire
assess fracture history
food frequency questionnaire
assess calcium and vitamin D food frequency
physical activity questionnaire
assess physical activity level
sun exposure questionnaire
assess sunlight exposure
follow-up questionnaire on overall health
assess for any changes in inflammatory bowel disease treatment since last visit

Full Information

First Posted
March 23, 2020
Last Updated
October 9, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04331639
Brief Title
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Official Title
Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
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 Information:
Title
vitamin D target
Description
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL
Time Frame
at study conclusion, up to 64 weeks
Secondary Outcome Measure Information:
Title
change in vitamin D level
Description
assess change in serum 25-OHD level from study entry to study conclusion
Time Frame
at study conclusion, up to 64 weeks
Title
vitamin D binding protein
Description
assessing vitamin D binding protein and free vitamin D
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
parathyroid hormone
Description
assessing parathyroid hormone
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
serum safety parameter
Description
evaluate serum calcium level
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
urine safety parameter
Description
evaluate urinary calcium to creatinine ratio
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
bone mineral density
Description
assess changes in bone density and body composition as assessed by DXA scan, when clinically available
Time Frame
at study conclusion, up to 64 weeks, when clinically available
Title
markers of bone turnover
Description
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.
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
inflammatory bowel disease treatment parameters
Description
assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available
Time Frame
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
Title
cytokine measurements
Description
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.
Time Frame
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Title
c-reactive protein
Description
evaluating c-reactive protein
Time Frame
at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
Title
erythrocyte sedimentation rate
Description
evaluating erythrocyte sedimentation rate
Time Frame
at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
Title
health-related quality of life questionnaire for inflammatory bowel disease
Description
assess quality of life measures in children with inflammatory bowel disease
Time Frame
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Title
baseline questionnaire on overall health
Description
assess overall health questionnaire
Time Frame
at 0 weeks (entry into study)
Title
fracture history questionnaire
Description
assess fracture history
Time Frame
at 0 weeks (entry into study)
Title
food frequency questionnaire
Description
assess calcium and vitamin D food frequency
Time Frame
at 0 weeks (entry into study)
Title
physical activity questionnaire
Description
assess physical activity level
Time Frame
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Title
sun exposure questionnaire
Description
assess sunlight exposure
Time Frame
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
Title
follow-up questionnaire on overall health
Description
assess for any changes in inflammatory bowel disease treatment since last visit
Time Frame
at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Gordon, MD
Phone
617-355-7476
Email
rebecca.gordon@childrens.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Gordon, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Gordon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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