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

February 27, 2025 updated by: Rebecca Gordon, Boston Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
vitamin D target
Time Frame: at study conclusion, up to 64 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in vitamin D level
Time Frame: at study conclusion, up to 64 weeks
assess change in serum 25-OHD level from study entry to study conclusion
at study conclusion, up to 64 weeks
vitamin D binding protein
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
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
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
assessing parathyroid hormone
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
serum safety parameter
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
evaluate serum calcium level
at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
urine safety parameter
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
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
Time Frame: at study conclusion, up to 64 weeks, when clinically available
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
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
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
Time Frame: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
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
Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
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
Time Frame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
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
Time Frame: at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available
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
Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
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
Time Frame: at 0 weeks (entry into study)
assess overall health questionnaire
at 0 weeks (entry into study)
fracture history questionnaire
Time Frame: at 0 weeks (entry into study)
assess fracture history
at 0 weeks (entry into study)
food frequency questionnaire
Time Frame: at 0 weeks (entry into study)
assess calcium and vitamin D food frequency
at 0 weeks (entry into study)
physical activity questionnaire
Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
assess physical activity level
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
sun exposure questionnaire
Time Frame: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
assess sunlight exposure
at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
follow-up questionnaire on overall health
Time Frame: at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rebecca Gordon, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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