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

NCT ID: NCT00227136

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2005-09-30

Brief 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.

Detailed 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.

Conditions

Carcinoid Tumors; Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

5-Hydroxy-Tryptamine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Principal Investigators

Stan HM Van Uum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

St. Joseph's Health Care

London, Ontario, Canada

Countries

Canada

Other Identifiers

5-HTPSVU

Identifier Type: -

Identifier Source: org_study_id