RECRUITING

5HTP Regulation Of Asthma In Children

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Conditions

Mild or Moderate Asthma With Allergic Sensitization

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

5HTP Regulation Of Asthma In Children

Quick Facts

Study Start:2021-02-11
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04160910

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.

Ages Eligible for Study:8 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 8-18 Years of Age
  2. * Mild to Moderate Asthma based on ATS guidelines
  3. * Positive Allergy Test (positive skin or serum IgE)
  4. * Weight ≥ 70 lbs (32 kg)
  5. * CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
  6. * 25 (total score range is 0 to 142)
  7. * Ability to comply with study visits and study procedures
  8. * Informed Consent by participant and if applicable the parent or legal guardian
  1. * Currently taking a SSRI
  2. * Taking a leukotriene inhibitor (montelukast, Zileuton)
  3. * Severe Asthma Based on ATS Guidelines
  4. * Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
  5. * Medical History of Adverse Reaction to 5HTP
  6. * Physical findings that would compromise the safety of the study or the quality of the study data

Contacts and Locations

Study Contact

Kirsten Kloepfer, MD
CONTACT
(317) 278-7860
kloepfer@iu.edu
Patrick Campbell, BS
CONTACT
(317) 278-7117
ptc@iu.edu

Principal Investigator

Kirsten Kloepfer, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Kirsten Kloepfer, MD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-11
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-02-11
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Mild or Moderate Asthma With Allergic Sensitization