NCT04160910RecruitingPhase 2
5HTP Regulation Of Asthma In Children
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Oct 2019
- Start date
- 11 Feb 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Indiana University
- Diseases
- Asthma
- NCT number
- NCT04160910
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 11 Feb 2021 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently taking a SSRI
- Taking a leukotriene inhibitor (montelukast, Zileuton)
- Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
Other illness
- Medical History of Adverse Reaction to 5HTP
Other
- Severe Asthma Based on ATS Guidelines
- Physical findings that would compromise the safety of the study or the quality of the study data
Who the study is looking for
- 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
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.