5HTP Regulation Of Asthma In Children
Indiana University
20 participants
Feb 11, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
- (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 Criteria6
- Currently taking a SSRI
- Taking a leukotriene inhibitor (montelukast, Zileuton)
- Severe Asthma Based on ATS Guidelines
- Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
- Medical History of Adverse Reaction to 5HTP
- Physical findings that would compromise the safety of the study or the quality of the study data
Interventions
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04160910