Health TrialsbyHealthPanel

5HTP Regulation Of Asthma In Children

ConditionMild or Moderate Asthma With Allergic Sensitization
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-18
SponsorIndiana University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Currently taking a SSRI

Taking a leukotriene inhibitor (montelukast, Zileuton)

Severe Asthma Based on ATS Guidelines

Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: 5-hydroxytryptophanActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77

Time frame
77 days

Secondary outcomes

1

Blood will be obtained to assess Eosinophil Count

Will be performed at Baseline, Day 28, and Day 49, and Day 77

Time frame
77 days
2

Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression

Changes in Anxiety/Depression will be determined via questionnaire that will be administered at Baseline, Day 28, and Day 49, and Day 77 . Will use the Center for Epidemiological Studies Depression Scale for Children (CES-DC) to measure depression and Screen for Child Anxiety Related Disorders (SCARED)

Time frame
77 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
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