5HTP Regulation Of Asthma In Children
Indiana University
Summary
The purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo. This will be decided randomly. Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks.
Description
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC \& SCARED). The r…
Eligibility
- Age range
- 8–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 8-18 Years of Age * Mild to Moderate Asthma based on ATS guidelines * Positive Allergy Test (positive skin or serum IgE) * Weight ≥ 70 lbs (32 kg) * CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off * 25 (total score range is 0 to 142) * Ability to comply with study visits and study procedures * Informed Consent by participant and if applicable the parent or legal guardian Exclusion Criteria: * Currently taking a SSRI * Taking a leukotriene inhibitor (montelukast, Zileuton) * Severe Asthma Based on ATS Guidelines * Taking a biologic medication…
Interventions
- Drug5-Hydroxytryptophan
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
- DrugPlacebo
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Location
- Indiana UniversityIndianapolis, Indiana