5HTP Regulation Of Asthma In Children

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.

Conditions

Mild or Moderate Asthma With Allergic Sensitization

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Study Overview

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Study Details

Study overview

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.

5HTP Regulation Of Asthma In Children

5HTP Regulation Of Asthma In Children

Condition
Mild or Moderate Asthma With Allergic Sensitization
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

8 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indiana University,

Kirsten Kloepfer, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

2024-12