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.
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC \& SCARED). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression. * Aim 1: Test that 5HTP improves lung function in children with allergic asthma * Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1 * Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Indiana University
Indianapolis, Indiana, United States
RECRUITINGPulmonary 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
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
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
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