Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03039257
  4. Details
NCT03039257 Clinical Trial

Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:
Single, High Dose Vitamin A Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation and Its Role on MBI-LCBI Rates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03039257
Other study ID # 2016-5937
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2017
Est. completion date March 28, 2018

Study information
Verified date May 2018
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to establish that single dose vitamin A supplementation is feasible and safe in pediatric and young adult bone marrow transplant recipients until day +30 (± 7 days) after hematopoietic stem cell transplantation.

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), likely via decreased gut permeability, and they hypothesize supplemental vitamin A at the time of HSCT can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). A 3x3 dose escalation/de-escalation study design will be used to determine the safety and dosing required to maintain vitamin A levels in the upper quartile of normal range for age at day +30 (± 7 days) with single dose vitamin A supplementation prior to hematopoietic stem cell transplantation.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 28, 2018
Est. primary completion date January 17, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year and older
Eligibility Inclusion Criteria:

- Any patient undergoing HSCT.

Exclusion Criteria:

- Vitamin A hypersensitivity or allergy.

- Age less than 1 year at time of transplant.

- Baseline pre-HSCT vitamin A levels higher than the upper quartile of normal range for age.

- Enteral feeding or medication intolerance.

- Pregnancy.

Study Design

Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplant

Intervention

Dietary Supplement:
• Vitamin A
Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vitamin A Level Vitamin A level will be measured 30 days after HSCT. 30 days after HSCT
Secondary Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) Incidence of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) 100 days after HSCT. 100 days after HSCT
See also
  Status Clinical Trial Phase
Withdrawn NCT02451462 - Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients N/A
Terminated NCT01215981 - Influenza Vaccine Post Allogeneic Transplant N/A
Recruiting NCT03613532 - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN Phase 1
Completed NCT01337648 - Radiation Biodosimetry in Children Undergoing Total Body Irradiation N/A
Recruiting NCT03250546 - Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant Phase 2
Recruiting NCT02982902 - T Cell Therapy of Opportunistic Cytomegalovirus Infection Early Phase 1
Completed NCT02441075 - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014 N/A
Completed NCT04549038 - Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients N/A
Completed NCT03886909 - Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant N/A
Not yet recruiting NCT05722210 - Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Not yet recruiting NCT06328127 - Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors N/A
Completed NCT03509051 - Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation N/A
Terminated NCT02350777 - T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT04853277 - Patient Reported Outcomes and Patient Education in Cellular Therapy Patients N/A
Completed NCT03378089 - Music Therapy and Hematopoietic Stem Cell Transplant N/A
Completed NCT03202849 - A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation N/A
Completed NCT01581164 - Studies of the Immune Response to Vaccination After Hematopoietic Stem Cell Transplantation N/A
Completed NCT01504152 - International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center N/A
Completed NCT03759262 - Ultra-high Dose Vitamin D for HSCT Phase 1
Recruiting NCT04263597 - Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients Phase 1/Phase 2