High Dose Vitamin A in Preventing Gastrointestinal GVHD in Participants Undergoing Donor Stem Cell Transplant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03719092|
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Allogeneic Hematopoietic Stem Cell Transplantation Recipient||Dietary Supplement: Vitamin A Compound||Not Applicable|
I. To assess the feasibility and safety of pre-transplant single, high dose vitamin A supplementation in adult allogeneic stem cell transplant recipients until day +28 after transplant.
OUTLINE: This is a dose-escalation study.
Participants receive vitamin A compound orally (PO) or enterally once prior to stem cell transplant.
After completion of study treatment, participants are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single, High Dose Vitamin A Replacement in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Prevention (vitamin A compound)
Participants receive vitamin A compound PO or enterally once prior to stem cell transplant.
Dietary Supplement: Vitamin A Compound
Given PO or enterally
- 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 ]
- Incidence of gastrointestinal graft versus host disease [ Time Frame: Up to day 180 after stem cell transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719092
|Contact: Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Rachel Dalton||Rachel.Dalton@osumc.edu|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Not yet recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Hannah Choe, MD 614-293-5428 Hannah.Choe@osumc.edu|
|Principal Investigator: Hannah Choe, MD|
|Principal Investigator:||Hannah Choe, MD||Ohio State University Comprehensive Cancer Center|