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RECRUITING Phase 2 ClinicalTrials.gov

5HTP Regulation Of Asthma In Children

Sponsor: Indiana University • ClinicalTrials.gov ID: NCT04160910

Registry updated: 2026-10-01
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Description

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.

Interventions

  • 5-Hydroxytryptophan (Drug)
    Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
  • Placebo (Drug)
    Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study

Eligibility criteria

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 (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

Conditions

Mild or Moderate Asthma With Allergic Sensitization

Locations

  • Indiana University — Indianapolis, Indiana, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record