The purpose of this study is to determine if the supplement, Fisetin, can be used as a treatment option for common variable immunodeficiency (CVID) by comparing its efficacy to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Change in immunophenotyping of peripheral T lymphocytes
Measured by percentage of activated CD4+25+ T cells
Time frame: Baseline, 6 months
Change in Forced Vital Capacity (FVC)
Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L)
Time frame: Baseline, 6 months
Change in radiologic imaging in subjects
Number of subjects to have a 10% improvement with the CT scoring system. Radiologist will score the CT scans at each time point and changes in score at each time point will be noted.
Time frame: Baseline, 3 months, 6 months
Use of MRI imaging for assessment of GLILD
Number of MRI images that were used to assess for GLILD compared to High-resolution Computed Tomography (HRCT) use
Time frame: 6 months
Infectious complications
Number of subjects to experience infectious complications
Time frame: 6 months
Adverse Events
Number of adverse events reported
Time frame: 6 months
Change in quality of life
Measured using the RAND 36-Short Form Survey Instrument (SF-36). The SF-36 Health Survey is a 36-item, participant-reported survey that measures patient health and disability. Possible scores range from 0 to 100, with 0 indicating maximum disability, and 100 indicating no disability
Time frame: Baseline, 6 months
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Change in 6 minute walk test
Number of subjects to have a 10% improvement in 6 minute walk test. The 6 minute walk test measures the distance a person is able to walk in 6 minutes.
Time frame: Baseline, 6 months