A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D and A Supplementation
Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
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.
A single dose of Vitamin D plus a placebo will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
100 days after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MBI-LCBI
Time Frame: 100 days after transplant
Incidence of MBI-LCBI at day +100 after transplant.
100 days after transplant
Treatment Related Mortality
Time Frame: 100 days after transplant
Treatment related mortality at day +100 after transplant.
100 days after transplant
Overall Survival
Time Frame: 1 year after transplant
Overall survival at 1 year after transplant.
1 year after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stella Davies, MBBS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

August 14, 2022

Study Completion (Actual)

May 6, 2023

Study Registration Dates

First Submitted

June 27, 2017

First Submitted That Met QC Criteria

June 27, 2017

First Posted (Actual)

June 29, 2017

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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