Indiana University
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Location contact
Lisa Bendy
CONTACT
Patrick T Campbell, BS
CONTACT
NCT Number: NCT04160910
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.
Interested in participating?
Request Info8 year–18 year
All sexes
Interventional
Phase 2
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Lisa Bendy
CONTACT
Patrick T Campbell, BS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Other names: 5HTP
Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
Time frame: 77 days
Pulmonary function testing will be performed at Baseline, Day 28, and Day 49, and Day 77
Time frame: 77 days
Will be performed at Baseline, Day 28, and Day 49, and Day 77
Time frame: 77 days
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)
Contact information is provided by the study sponsor or research team.
Kirsten Kloepfer, MD
CONTACT
Patrick Campbell, BS
CONTACT
Indiana University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06860594
Astrocytoma, Astrocytoma, IDH-Mutant, Grade 2
Duarte, California, United States
View Trial DetailsNCT01804686
Blood Protein Disorders, Bronchial Diseases
Duarte, California, United States
View Trial DetailsNCT07634471
Follicular Lymphoma, Hemic and Lymphatic Diseases
Nashville, Tennessee, United States
View Trial DetailsNCT07609862
Blood Protein Disorders, Cardiovascular Diseases
Tianjin, China
View Trial Details