Allogeneic Hematopoietic Stem Cell Transplantation RecipientNCT03719092
High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
A study testing Vitamin A Compound and Best Practice in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation Recipient
- What is being tested?
- Vitamin A Compound and Best Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 19 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible
Who cannot join
- Vitamin A hypersensitivity or allergy
- Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening
- Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening
- Enteral feeding intolerance
- Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.
Read the detailed description
PRIMARY OBJECTIVES:
- . To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients.
SECONDARY OBJECTIVE:
- To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.
TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%.
CONTROL COHORT: Patients receive usual care.
After completion of study treatment, participants are followed up periodically.
- Being tested
- Vitamin A Compound, Best Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A CompoundDietary supplement
Also called A 313, Anti-Infective Vitamin, Antixerophthalmic Vitamin, Aquasol A
Given PO or enterally
Best PracticeOther
Also called Standard of care, standard therapy
Receive usual care
| Study group | Role | What they receive |
|---|---|---|
| Treatment Cohort (vitamin A compound) | Experimental | Participants receive vitamin A compound PO or enterally once prior to stem cell transplant.
once over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A. Receives: Dietary Supplement: Vitamin A Compound |
| Control Cohort (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity
Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.
determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.
Measured: Up to day 28
Secondary outcomes (2)
Incidence of gastrointestinal graft versus host disease
Cumulative incidence of GI GVHD will be calculated and graphed.
Measured: Up to day 180 after stem cell transplant
Incidence of Toxicity
The toxicity analysis will include summarization of the toxicity and tolerability will be tabulated by dose level and summarized. Severe (grade 3+) toxicities will be summarized as well by type as well as in summary format of hematologic vs. non-hematologic severe toxicity incidence.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start7 Feb 2020
- Primary completion30 Apr 2025
- Study completion19 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation RecipientStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Choe, MD, Ohio State University Comprehensive Cancer Center
- Investigators
- Hannah Choe, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719092
- Sponsor's protocol ID
- OSU-18078
- Other IDs
- NCI-2018-01838
- Status last verified
- Jul 2026
- First submitted
- 23 Oct 2018
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03719092
- Acronym / sponsor ID
- OSU-18078
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 19 Oct 2025 (actual)
- First posted
- 25 Oct 2018 (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.
This phase I trial studies the side effects and how well high dose vitamin A works in preventing gastrointestinal graft versus host disease (GVHD) in participants undergoing donor stem cell transplant. Vitamin A deficiency is associated with increased risk of gastrointestinal GVHD. Vitamin A regulates growth and differentiation of intestinal cells and may reduce risk of gastrointestinal GVHD.
Detailed description
PRIMARY OBJECTIVES:
- . To determine the biologically effective and tolerable dose (BETD) level of pretransplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients.
SECONDARY OBJECTIVE:
- To evaluate the feasibility of collecting stool and profiling the gut microbiome in relation to Vitamin A.
OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 cohorts.
TREATMENT COHORT: Patients receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant. Patients may receive vitamin A compound PO or enterally two weeks after stem cell transplant if vitamin A levels have not improved by at least 10%.
CONTROL COHORT: Patients receive usual care.
After completion of study treatment, participants are followed up periodically.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort (vitamin A compound) | Experimental | Dietary Supplement: Vitamin A CompoundParticipants receive vitamin A compound PO or enterally once prior to stem cell transplant. once over a given 24 hour period with or without food. We will re-dose at 2000 IU/kg (maximum 120,000 IU) if Week 2 Vitamin A levels remain within 10% of baseline Vitamin A. |
| Control Cohort (usual care) | Active comparator | Other: Best PracticePatients receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients planned to undergo an allogeneic stem cell transplant (SCT) with an human leukocyte antigen (HLA)-matched (unrelated or related) or 1 allele mismatched (7/8) donor or haploidentical donor who received either myeloablative or nonmyeloablative conditioning for hematologic malignancies are eligible
Key exclusion criteria (6 listed)
- Vitamin A hypersensitivity or allergy
- Abnormal liver enzymes outside of the institutional laboratory normal range within 30 days of screening
- Abnormal total, indirect, or direct bilirubin outside of the institutional laboratory normal range within 30 days of screening
- Enteral feeding intolerance
- Medication intolerance - history of allergic reaction to Vitamin A or other history of discontinuation to study drug due to adverse effect
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 A CompoundAlso: A 313, Anti-Infective Vitamin, Antixerophthalmic Vitamin, Aquasol AGiven PO or enterally | Dietary supplement | Treatment Cohort (vitamin A compound) |
| Best PracticeAlso: Standard of care, standard therapyReceive usual care | Other | Control Cohort (usual care) |
Primary outcome
Vitamin A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity
Time frame: Up to day 28
Determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients. determining a Vitamin A dose administered within 14 days prior to transplant that maintains level in the upper quartile of normal range for sex at day 28 (+/- 7 days) after stem cell infusion as well as tolerable in adult allogeneic stem cell transplant recipients.
2 secondary outcomes
Incidence of gastrointestinal graft versus host disease
Time frame: Up to day 180 after stem cell transplant
Incidence of Toxicity
Time frame: Up to 28 days
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 Sep 2026.
- The JameslineLink provided by the sponsor.
- 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.
Hannah Choe, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A Compound and Best Practice in people with Allogeneic Hematopoietic Stem Cell Transplantation Recipient, run by Ohio State University Comprehensive Cancer Center 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 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: finished, as of the sponsor's last update on 2 Sep 2026. 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 A dose that achieves level in the upper quartile of normal range for sex in at least 2/3 cases without dose limiting toxicity (time frame: Up to day 28). 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 2 Sep 2026.