Hematopoietic Stem Cell TransplantNCT03202849
A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation
A study testing Vitamin D and A in people with Hematopoietic Stem Cell Transplant, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplant
- What is being tested?
- Vitamin D and A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 6 May 2023
- 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
- Scheduled for allogeneic stem cell transplant
- Vitamin D level < 50 ng/ml
- Vitamin A level < 75th centile for age
- Able to tolerate enteral vitamin dose administration
Who cannot join
- History of pathologic fractures
- Known history of nephrocalcinosis or nephrolithiasis
- Current granulomatous disease
- ALT > 10X ULN for age prior to administration of vitamin A
- Ongoing raised intracranial pressure
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
The investigators hypothesize that supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.
Read the detailed description
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.
This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
- Conditions
- Hematopoietic Stem Cell Transplant
- Being tested
- Vitamin D and A, Vitamin D and Placebo
- Keywords
- hematopoietic stem cell transplant, vitamin a, vitamin d
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D and ADietary supplement
A single dose of Vitamin A and Vitamin D will be given.
Vitamin D and PlaceboDietary supplement
A single dose of Vitamin D plus a placebo will be given.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D and A Supplementation | Experimental | Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT. Receives: Dietary Supplement: Vitamin D and A |
| Vitamin D Supplementation with Placebo | Active comparator | Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT. Receives: Dietary Supplement: Vitamin D and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI GVHD
Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
Measured: 100 days after transplant
Secondary outcomes (3)
MBI-LCBI
Incidence of MBI-LCBI at day +100 after transplant.
Measured: 100 days after transplant
Treatment Related Mortality
Treatment related mortality at day +100 after transplant.
Measured: 100 days after transplant
Overall Survival
Overall survival at 1 year after transplant.
Measured: 1 year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start19 Feb 2018
- Primary completion14 Aug 2022
- Study completion6 May 2023
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 Hematopoietic Stem Cell TransplantStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Davies, MBBS, PhD, MRCP, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202849
- Sponsor's protocol ID
- 2016-9480
- Status last verified
- May 2023
- First submitted
- 27 Jun 2017
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khandelwal P, Langenberg L, Luebbering N, Lake KE, Butcher A, Bota K, Ramos KN, Taggart C, Choe H, Vasu S, Teusink-Cross A, Koo J, Wallace G, Romick-Rosendale L, Watanabe-Chailland M, Haslam DB, Lane A, Davies SM. A randomized phase 2 trial of oral vitamin A for graft-versus-host disease in children and young adults. Blood. 2024 Mar 21;143(12):1181-1192. doi: 10.1182/blood.2023022865.
PubMed 38227933
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03202849
- Acronym / sponsor ID
- 2016-9480
- Conditions
- Hematopoietic Stem Cell Transplant
- Keywords
- hematopoietic stem cell transplant, vitamin a, vitamin d
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 29 Jun 2017 (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 supplementation with vitamins A and D will reduce the incidence of acute gastrointestinal graft versus host disease (GI GVHD) compared with supplementation with vitamin D alone.
Detailed description
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.
This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D and A Supplementation | Experimental | Dietary Supplement: Vitamin D and AParticipants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT. |
| Vitamin D Supplementation with Placebo | Active comparator | Dietary Supplement: Vitamin D and PlaceboParticipants receive a single dose of vitamin D and a single dose of placebo prior to HSCT. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for allogeneic stem cell transplant
- Vitamin D level < 50 ng/ml
- Vitamin A level < 75th centile for age
- Able to tolerate enteral vitamin dose administration
Key exclusion criteria (6 listed)
- History of pathologic fractures
- Known history of nephrocalcinosis or nephrolithiasis
- Current granulomatous disease
- ALT > 10X ULN for age prior to administration of vitamin A
- Ongoing raised intracranial pressure
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 and AA single dose of Vitamin A and Vitamin D will be given. | Dietary supplement | Vitamin D and A Supplementation |
| Vitamin D and PlaceboA single dose of Vitamin D plus a placebo will be given. | Dietary supplement | Vitamin D Supplementation with Placebo |
Primary outcome
GI GVHD
Time frame: 100 days after transplant
Incidence of acute GI GVHD at day +100 after transplant. GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
3 secondary outcomes
MBI-LCBI
Time frame: 100 days after transplant
Treatment Related Mortality
Time frame: 100 days after transplant
Overall Survival
Time frame: 1 year after transplant
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 12 May 2023.
- Derived from this study: PubMed 38227933Khandelwal P, Langenberg L, Luebbering N, Lake KE, Butcher A, Bota K, Ramos KN, Taggart C, Choe H, Vasu S, Teusink-Cross A, Koo J, Wallace G, Romick-Rosendale L, Watanabe-Chailland M, Haslam DB, Lane A, Davies SM. A randomized phase 2 trial of oral vitamin A for graft-versus-host disease in children and young adults. Blood. 2024 Mar 21;143(12):1181-1192. doi: 10.1182/blood.2023022865.
- 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.
Stella Davies, MBBS, PhD, MRCP 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 Vitamin D and A in people with Hematopoietic Stem Cell Transplant, 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 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: finished, as of the sponsor's last update on 12 May 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?
GI GVHD (time frame: 100 days after transplant). 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 NCT03202849, 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 12 May 2023; AzTrials last refreshed its copy on 3 Nov 2026.