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

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ClinicalTrials.gov Identifier: NCT03202849
Recruitment Status : Recruiting
First Posted : June 29, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplant Dietary Supplement: Vitamin D and A Dietary Supplement: Vitamin D and Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Actual Study Start Date : February 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. MBI-LCBI [ Time Frame: 100 days after transplant ]
    Incidence of MBI-LCBI at day +100 after transplant.

  2. Treatment Related Mortality [ Time Frame: 100 days after transplant ]
    Treatment related mortality at day +100 after transplant.

  3. Overall Survival [ Time Frame: 1 year after transplant ]
    Overall survival at 1 year after transplant.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202849


Contacts
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Contact: Katie Hendy (513) 803-7450 Katherine.Hendy@cchmc.org
Contact: Jenn Bravo (513) 803-4425 Jennifer.Bravo@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Katie Hendy    513-803-7450    Katherine.Hendy@cchmc.org   
Principal Investigator: Stella Davies, MBBS, PhD, MRCP         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Stella Davies, MBBS, PhD, MRCP Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03202849     History of Changes
Other Study ID Numbers: 2016-9480
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Children's Hospital Medical Center, Cincinnati:
hematopoietic stem cell transplant
vitamin a
vitamin d

Additional relevant MeSH terms:
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Vitamins
Vitamin D
Ergocalciferols
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents