5HTP Regulation Of Asthma In Children

Conditions

• Mild or Moderate Asthma With Allergic Sensitization

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Feb 11, 2021

Status verified

Feb 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: 5-hydroxytryptophan
  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 Comparator: Placebo
  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

Primary Outcome Measure

Pulmonary Function Testing will be performed to assess for a change in Forced Expiratory Volume at one second (FEV1) [ Time Frame: 77 days ]

Central Contacts

• Kirsten Kloepfer, MD
  (317) 278-7860
  [email protected]
• Patrick Campbell, BS
  (317) 278-7117
  [email protected]

Locations (1)

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