5HTP Regulation Of Asthma In Children

Who is this study for? Child patients with Asthma
What treatments are being studied? 5-Hydroxytryptophan
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Indiana
Indiana University
RECRUITING
Indianapolis
Contact Information
Primary
Kirsten Kloepfer, MD
kloepfer@iu.edu
(317) 278-7860
Backup
Patrick Campbell, BS
ptc@iu.edu
(317) 278-7117
Time Frame
Start Date: 2021-02-11
Estimated Completion Date: 2026-01-05
Participants
Target number of participants: 20
Treatments
Active_comparator: 5-hydroxytryptophan
Dosage of 5-hydroxytryptophan will be determined by weight:~If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day
Placebo_comparator: Placebo
Dosage of placebo will be determined by weight:~If subject weighs less than 100lbs: 50mg twice a day If subject weights more than 100lbs: 100mg twice a day
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov