Back to resultsTime-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Primary Purpose
Fanconi Anemia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-Restricted Feeding
Sponsored by
About this trial
This is an interventional other trial for Fanconi Anemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of FA with neuroinflammation
- Age ≥ 12 years old
Exclusion Criteria:
- None
Sites / Locations
- Cincinnati Children's Hospital Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Time-Restricted Feeding
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with neuroinflammation
Presence of neuroinflammation will be measured with a clinical head MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT05598515
First Posted
October 25, 2022
Last Updated
September 20, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT05598515
Brief Title
Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Official Title
Single Arm Prospective Trial of Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main reason for this research study is to determine whether time-restricted eating will reduce inflammation in the bodies of persons with Fanconi anemia (FA) and whether time-restricted eating will improve function in people with FA and neurological changes. Participants will be asked to eat for only 8 hours out of 24 hours in a day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fanconi Anemia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Time-Restricted Feeding
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted Feeding
Intervention Description
Participants will be asked to eat for only 8 hours out of 24 hours in a day.
Primary Outcome Measure Information:
Title
Number of participants with neuroinflammation
Description
Presence of neuroinflammation will be measured with a clinical head MRI
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of FA with neuroinflammation
Age ≥ 12 years old
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ormarie Vazquez Silva
Phone
513-803-0183
Email
Ormarie.VazquezSilva@cchmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stella Davies, MBBS, PhD, MRCP
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ormarie Vazquez Silva
Phone
513-803-0183
Email
Ormarie.VazquezSilva@cchmc.org
First Name & Middle Initial & Last Name & Degree
Stella Davies, MBBS, PhD, MRCP
12. IPD Sharing Statement
Learn more about this trial
Time-restricted Feeding to Reduce Inflammation in Fanconi Anemia
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