Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

Neuroendocrine Tumors Clinical Trial

Official title:

Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00227136
• Other study ID #: 5-HTPSVU
• Status: Terminated
• Phase: Phase 3
• First received: September 23, 2005
• Last updated: April 11, 2018
• Start date: May 2005
• Est. completion date: September 2005

Study information

• Verified date: July 2006
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research study looking at the effect of 5-Hydroxy Tryptophan (5-HTP) on urine excretion of 5-Hydroxyindolacetic acid (5-HIAA). 5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. Increased levels of 5-HIAA in the urine can be found in a specific type of cancer, called carcinoid tumor. This study will examine the effect of oral 5-HTP intake on 5-HIAA excretion. Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Description:

5-HTP is a common over the counter product that is sold in natural food stores and via the Internet. It is claimed to improve sleep problems, depression, anxiety, compulsive disorders, restless leg syndrome, migraines, fibromyalgia, and low pain threshold.Increased levels of 5-HIAA in the urine can be a of a specific type of cancer, called carcinoid tumor. Urinary 5-HIAA levels can also be increased by a number of food products and drugs. Oral 5-HTP is not known as a cause of elevation of 5-HIAA in urine. However, recent information suggests that 5-HTP may cause an increase.

In this study we examine the effect of oral 5-HTP intake (100 mg at bedtime for 10 days) on 5-HIAA excretion in the urine, following a prospective, double-blind placebo-controlled study design.

Understanding this effect may help to determine which tests should be done in a patient with increased 5-HIAA excretion who's also taking 5-HTP.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older

• in good health

Exclusion Criteria:

• Pregnancy

• Intake of drugs that affect 5-HIAA excretion in urine

• Anti-depressants

• Participation in other studies

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoid Tumors
• Neuroendocrine Tumors

Intervention

Drug:
• 5-Hydroxy-Tryptamine

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of 5-HIAA
Primary	Plasma Chromogranin A
Secondary	Side effects