Inflammatory Bowel DiseaseNCT04331639
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
An observational study of Inflammatory Bowel Disease and Crohn Disease, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis
- What is being tested?
- vitamin D3
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Rebecca Gordon, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- vitamin D3
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D3Dietary supplement
Also called cholecalciferol
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin D target
assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng/mL
Measured: at study conclusion, up to 64 weeks
Secondary outcomes (18)
change in vitamin D level
assess change in serum 25-OHD level from study entry to study conclusion
Measured: at study conclusion, up to 64 weeks
vitamin D binding protein
assessing vitamin D binding protein and free vitamin D
Measured: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
parathyroid hormone
assessing parathyroid hormone
Measured: at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)
serum safety parameter
evaluate serum calcium level
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
c-reactive protein
evaluating c-reactive protein
Measured: 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
Measured: 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
Measured: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
baseline questionnaire on overall health
assess overall health questionnaire
Measured: at 0 weeks (entry into study)
fracture history questionnaire
assess fracture history
Measured: at 0 weeks (entry into study)
food frequency questionnaire
assess calcium and vitamin D food frequency
Measured: at 0 weeks (entry into study)
physical activity questionnaire
assess physical activity level
Measured: at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)
sun exposure questionnaire
assess sunlight exposure
Measured: 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
Measured: at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Nov 2020
- Primary completion1 Sep 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Gordon, Boston Children's Hospital
- Investigators
- Rebecca Gordon, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331639
- Sponsor's protocol ID
- P00033424
- Status last verified
- Feb 2025
- First submitted
- 23 Mar 2020
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gordon RJ, Vishwanath V, Lavoie A, Mishra R, Rufo PA. Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease. J Pediatr. 2026 Jul;294:115084. doi: 10.1016/j.jpeds.2026.115084. Epub 2026 Mar 30.
PubMed 41921771
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab
- ClinicalTrials.gov ID
- NCT04331639
- Acronym / sponsor ID
- P00033424
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- See above. Enrolling all eligible participants, who wish to participate, until reach enrollment target.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin D3Also: cholecalciferolSubjects 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. | Dietary supplement | – |
Primary outcome
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
18 secondary outcomes
change in vitamin D level
Time frame: 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)
parathyroid hormone
Time frame: 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)
urine safety parameter
Time frame: 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
markers of bone turnover
Time frame: 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)
cytokine measurements
Time frame: 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
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
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)
baseline questionnaire on overall health
Time frame: at 0 weeks (entry into study)
fracture history questionnaire
Time frame: at 0 weeks (entry into study)
food frequency questionnaire
Time frame: 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)
sun exposure questionnaire
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Derived from this study: PubMed 41921771Gordon RJ, Vishwanath V, Lavoie A, Mishra R, Rufo PA. Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease. J Pediatr. 2026 Jul;294:115084. doi: 10.1016/j.jpeds.2026.115084. Epub 2026 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca Gordon, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Gordon, MD (617-355-7476, rebecca.gordon@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vitamin D target (time frame: at study conclusion, up to 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04331639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.