A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT03202849|
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : October 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic Stem Cell Transplant||Dietary Supplement: Vitamin D and A Dietary Supplement: Vitamin D and Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation|
|Actual Study Start Date :||February 19, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||July 2021|
Experimental: Vitamin D and A Supplementation
Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
Dietary Supplement: Vitamin D and A
A single dose of Vitamin A and Vitamin D will be given.
Active Comparator: Vitamin D Supplementation with Placebo
Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.
Dietary Supplement: Vitamin D and Placebo
A single dose of Vitamin D plus a placebo will be given.
- 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.
- MBI-LCBI [ Time Frame: 100 days after transplant ]Incidence of MBI-LCBI at day +100 after transplant.
- Treatment Related Mortality [ Time Frame: 100 days after transplant ]Treatment related mortality at day +100 after transplant.
- Overall Survival [ Time Frame: 1 year after transplant ]Overall survival at 1 year after 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): NCT03202849
|Contact: Katie Hendy||(513) 803-7450||Katherine.Hendy@cchmc.org|
|Contact: Jenn Bravo||(513) 803-4425||Jennifer.Bravo@cchmc.org|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Katie Hendy 513-803-7450 Katherine.Hendy@cchmc.org|
|Principal Investigator: Stella Davies, MBBS, PhD, MRCP|
|Principal Investigator:||Stella Davies, MBBS, PhD, MRCP||Children's Hospital Medical Center, Cincinnati|