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

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant
• Interventions: Dietary Supplement: Vitamin D and A; Dietary Supplement: Vitamin D and Placebo

• Registration Number: NCT03202849
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-27
• Study First Posted: 2017-06-29
• Study Start: 2018-02-19
• Primary Completion: 2022-08-14
• Status Verified: 2023-05
• Study Completion: 2023-05-06
• Last Update Submitted: 2023-05-11
• Last Update Posted: 2023-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D and A Supplementation	Vitamin D and A	Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
Vitamin D Supplementation with Placebo	Vitamin D and Placebo	Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.

Primary Outcome Measures

Name	Time	Method
GI GVHD	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.

Secondary Outcome Measures

Name	Time	Method
MBI-LCBI	100 days after transplant	Incidence of MBI-LCBI at day +100 after transplant.
Treatment Related Mortality	100 days after transplant	Treatment related mortality at day +100 after transplant.
Overall Survival	1 year after transplant	Overall survival at 1 year after transplant.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States