5HTP for Asthma in Children

Phase 2

Recruiting

Led By Kirsten Kloepfer, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 77 days

Summary

This trial is to study the effects of 5HTP on breathing and anxiety symptoms related to asthma. Subjects will be randomly assigned to take 5HTP or a placebo, then will switch at the halfway point. There are 5 study visits over 12 weeks.

Who is the study for?

This trial is for children aged 8-18 with mild to moderate allergic asthma, weighing at least 70 lbs. They must have a positive allergy test and be able to follow the study's procedures. Kids taking certain asthma medications or with severe asthma, adverse reactions to 5HTP, or on SSRIs cannot participate.

What is being tested?

The study tests if the supplement 5-hydroxytryptophan (5HTP) can help manage breathing and anxiety in asthmatic kids compared to a placebo. Participants are randomly assigned to one group then switch midway through the study, which spans roughly 12 weeks across five visits.

What are the potential side effects?

Potential side effects of taking 5HTP may include gastrointestinal issues like nausea or diarrhea, dizziness, sleepiness, muscle problems, or mood changes. The severity of these side effects can vary from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 77 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~77 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 77 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1)

Secondary study objectives

Blood will be obtained to assess Eosinophil Count

Anxiety

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: 5-hydroxytryptophanActive Control1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

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