Vitamin D DeficiencyNCT04818957
Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Hematopoietic Stem Cell Transplantation (HSCT), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vitamin D Deficiency, Hematopoietic Stem Cell Transplantation (HSCT)
- What is being tested?
- Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2021to 20 Apr 2022
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.
Who cannot join
- Subjects with 25OHD level >60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.
- Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The investigators hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.
Read the detailed description
The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.
- Being tested
- Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)Dietary supplement
Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Oral Thin Film (OTF) | Experimental | Study subjects will receive vitamin D OTF for a maximum of 12 weeks. Receives: Dietary Supplement: Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D Level
Number of participants who achieve 25OH vitamin D level >35ng/mL
Measured: 12 weeks from starting vitamin D supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start7 Jun 2021
- Primary completion6 Apr 2022
- Study completion20 Apr 2022
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 Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Bartlett, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiGregory Wallace, DO, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818957
- Sponsor's protocol ID
- 2021-0151
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartlett AL, Zhang G, Wallace G, McLean S, Myers KC, Teusink-Cross A, Taggart C, Patel B, Davidson R, Davies SM, Jodele S. Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant. Blood Adv. 2023 Aug 22;7(16):4555-4562. doi: 10.1182/bloodadvances.2023009855.
PubMed 37285801
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04818957
- Acronym / sponsor ID
- 2021-0151
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 26 Mar 2021 (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 hypothesize that vitamin D levels can be improved in hematopoietic stem cell transplantation (HSCT) recipients not responding or tolerating standard enteral supplementation options by using vitamin D oral thin film (OTF) administration.
Detailed description
The purpose of this study is to investigate efficacy of oral thin film (OTF) cholecalciferol (vitamin D3) replacement in hematopoietic stem cell transplantation (HSCT) recipients who failed to achieve or sustain adequate vitamin D levels after vitamin D supplementation using current standard of care, or those unable to take/tolerate currently available enteral vitamin D formulations. With oral thin film (OTF) cholecalciferol, investigators hope to significantly improve the ease of administration, restoring compliance and facilitating therapeutic vitamin D levels without relying on the gut for absorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Oral Thin Film (OTF) | Experimental | Dietary Supplement: Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)Study subjects will receive vitamin D OTF for a maximum of 12 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- HSCT recipients of any age with vitamin D levels ≤35 ng/mL, or unable to tolerate, or refractory to enteral supplementation formulations of Vitamin D will be offered Vitamin D OTF.
Key exclusion criteria (2 listed)
- Subjects with 25OHD level >60ng/mL. Subjects can be re-screened multiple times and enrolled later if they meet study criteria.
- Subjects with clinically significant and uncontrolled hypercalcemia as deemed by treating physician.
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 |
|---|---|---|
| Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema. | Dietary supplement | Vitamin D Oral Thin Film (OTF) |
Primary outcome
Vitamin D Level
Time frame: 12 weeks from starting vitamin D supplementation
Number of participants who achieve 25OH vitamin D level >35ng/mL
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 2 Mar 2023.
- Derived from this study: PubMed 37285801Bartlett AL, Zhang G, Wallace G, McLean S, Myers KC, Teusink-Cross A, Taggart C, Patel B, Davidson R, Davies SM, Jodele S. Optimized vitamin D repletion with oral thin film cholecalciferol in patients undergoing stem cell transplant. Blood Adv. 2023 Aug 22;7(16):4555-4562. doi: 10.1182/bloodadvances.2023009855.
- 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. This study is not recruiting at the moment.
Allison Bartlett, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Gregory Wallace, DO principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Thin Film (OTF) Cholecalciferol (Vitamin D3) in people with Vitamin D Deficiency and Hematopoietic Stem Cell Transplantation (HSCT), run by Children's Hospital Medical Center, Cincinnati 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 1 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 2 Mar 2023. 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?
Vitamin D Level (time frame: 12 weeks from starting vitamin D supplementation). 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 NCT04818957, 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 2 Mar 2023.