Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
Rajesh Kumar
Summary
The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease the proportion of infants with aT2 high endotype at the end of treatment, and secondarily decrease the number of wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.
Description
The study is designed as a single site, randomized, quadruple-masked, placebo-controlled, parallel group clinical trial. We will enroll 65 high risk infants with the PAI-1 risk genotype, who are less than 12 months of age, and will be randomized to one of two treatment groups. The treatment groups will be either oral isoflavone supplement (at doses similar to that seen in soy formula) or a matching placebo . Screening will occur throughout each year, with genotyping occurring at the first visit, and assumption of care of individuals with the risk genotype after randomization. There will be a…
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent. 2. Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment 3. High risk of asthma: As determined by one or more of the following: 1. A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR 2. Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR 3. atopic…
Interventions
- DrugSoy isoflavone
Soy isoflavone supplement (Novasoy) that contains isoflavones (genistein, daidzein, glycetein) given at a dose of genistein aglycone equivalents to provide the genistein dosing of 22.6 mg/day for children aged 2-10 months, and 30.3 mg/day children aged 10-24 months
- Drugmatching placebo
A matching placebo also administered twice daily.
Locations (2)
- Ann and Robert H Lurie Childrens Hospital of ChicagoChicago, Illinois
- Northwestern University Feinberg School of MedicineChicago, Illinois