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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5-hydroxytryptophan | Active Comparator | 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 | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Hydroxytryptophan | Drug | Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 77 days |
| Measure | Description | Time Frame |
|---|---|---|
| Blood will be obtained to assess Eosinophil Count | Will be performed at Baseline, Day 28, and Day 49, and Day 77 | 77 days |
| Questionnaires will be utilized to look for a decrease in symptoms for Anxiety/Depression Reduced Symptoms for Anxiety/Depression |
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Inclusion Criteria:
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
Ability to comply with study visits and study procedures
Informed Consent by participant and if applicable the parent or legal guardian
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kirsten Kloepfer, MD | Contact | (317) 278-7860 | kloepfer@iu.edu | |
| Patrick Campbell, BS | Contact | (317) 278-7117 | ptc@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kirsten Kloepfer, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006916 | 5-Hydroxytryptophan |
| ID | Term |
|---|---|
| D014364 | Tryptophan |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
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| Placebo | Drug | Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study |
|
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) |
| 77 days |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |