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

Hematopoietic Stem Cell Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03202849
• Other study ID #: 2016-9480
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: May 6, 2023

Study information

• Verified date: May 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 6, 2023
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic Stem Cell Transplant

Intervention

Dietary Supplement:
• Vitamin D and A
A single dose of Vitamin A and Vitamin D will be given.
• Vitamin D and Placebo
A single dose of Vitamin D plus a placebo will be given.

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	GI GVHD	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	MBI-LCBI	Incidence of MBI-LCBI at day +100 after transplant.	100 days after transplant
Secondary	Treatment Related Mortality	Treatment related mortality at day +100 after transplant.	100 days after transplant
Secondary	Overall Survival	Overall survival at 1 year after transplant.	1 year after transplant