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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2023-05-06

Brief Summary

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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.

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Detailed Description

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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

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Hematopoietic Stem Cell Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D and A Supplementation

Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.

Group Type EXPERIMENTAL

Vitamin D and A

Intervention Type DIETARY_SUPPLEMENT

A single dose of Vitamin A and Vitamin D will be given.

Vitamin D Supplementation with Placebo

Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.

Group Type ACTIVE_COMPARATOR

Vitamin D and Placebo

Intervention Type DIETARY_SUPPLEMENT

A single dose of Vitamin D plus a placebo will be given.

Interventions

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Vitamin D and A

A single dose of Vitamin A and Vitamin D will be given.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D and Placebo

A single dose of Vitamin D plus a placebo will be given.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No