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
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
June 29, 2017
CompletedStudy Start
First participant enrolled
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2023
CompletedMay 12, 2023
May 1, 2023
4.5 years
June 27, 2017
May 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
MBI-LCBI
100 days after transplant
Treatment Related Mortality
100 days after transplant
Overall Survival
1 year after transplant
Study Arms (2)
Vitamin D and A Supplementation
EXPERIMENTALParticipants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
Vitamin D Supplementation with Placebo
ACTIVE COMPARATORParticipants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.
Interventions
A single dose of Vitamin A and Vitamin D will be given.
A single dose of Vitamin D plus a placebo will be given.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
Khandelwal P, Langenberg L, Luebbering N, Lake KE, Butcher A, Bota K, Ramos KN, Taggart C, Choe H, Vasu S, Teusink-Cross A, Koo J, Wallace G, Romick-Rosendale L, Watanabe-Chailland M, Haslam DB, Lane A, Davies SM. A randomized phase 2 trial of oral vitamin A for graft-versus-host disease in children and young adults. Blood. 2024 Mar 21;143(12):1181-1192. doi: 10.1182/blood.2023022865.
PMID: 38227933DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Davies, MBBS, PhD, MRCP
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2017
First Posted
June 29, 2017
Study Start
February 19, 2018
Primary Completion
August 14, 2022
Study Completion
May 6, 2023
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share