Inflammatory Bowel Disease (IBD)NCT02256605
Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens
An observational study of Inflammatory Bowel Disease (IBD), run by Nemours Children's Clinic at 1 site in United States.
Trial summary
The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or deficient. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- Vitamin D-3
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level as part of a clinical practice/standard of care.
Who may be able to join
- Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
- Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit
Who cannot join
- Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
- Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- Vitamin D-3
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D-3Dietary supplement
Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.
| Study group | Role | What they receive |
|---|---|---|
| Insufficient Group | D-3 Chewable Wafer - 14,000 IU/wafer weekly Vitamin D-3 Caps - 2,000 IU/Cap daily Vitamin D-3 Liquid - 5,000 IU/ml (0.4) ml daily Receives: Dietary Supplement: Vitamin D-3 | |
| Deficient Group | D-3 Chewable Wafer - 50,000 IU/wafer weekly Vitamin D-3 Liquid - 5,000 IU/ml daily Receives: Dietary Supplement: Vitamin D-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
25 \(OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startNov 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- NASPGHAN Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256605
- Sponsor's protocol ID
- 524835
- Status last verified
- May 2015
- First submitted
- 1 Oct 2014
- Last updated
- 29 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens
- ClinicalTrials.gov ID
- NCT02256605
- Acronym / sponsor ID
- 524835
- Conditions
- Inflammatory Bowel Disease (IBD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- NASPGHAN Foundation
- Study start
- Nov 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Oct 2014 (estimated)
- 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 purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D [25(OH)D] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insufficient Group | – | Dietary Supplement: Vitamin D-3D-3 Chewable Wafer - 14,000 IU/wafer weekly Vitamin D-3 Caps - 2,000 IU/Cap daily Vitamin D-3 Liquid - 5,000 IU/ml (0.4) ml daily |
| Deficient Group | – | Dietary Supplement: Vitamin D-3D-3 Chewable Wafer - 50,000 IU/wafer weekly Vitamin D-3 Liquid - 5,000 IU/ml daily |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a rountine clinic visit or lab draw that includes a 25(OH)D level as part of a clinical practice/standard of care.
Key inclusion criteria (2 listed)
- Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
- Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit
Key exclusion criteria (2 listed)
- Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
- Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study
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 D-3Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size. | Dietary supplement | Deficient Group, Insufficient Group |
Primary outcome
25 (OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 (IBD), run by Nemours Children's Clinic 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 May 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25 (OH)D level will be recorded at baseline and at 8 weeks as an absolute value (ratio data) and the percentage and direction (increase or decrease) of change between baseline and end of treatment level. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2015.