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

• Sponsor: University of Western Ontario, Canada (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00227136
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoid Tumors; Neuroendocrine Tumors	Drug: 5-Hydroxy-Tryptamine	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Diagnostic
• Official Title: Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
• Study Start Date: May 1, 2005
• Study Completion Date: Sep 1, 2005

Outcome Measures

Primary Outcome Measures

1. Urinary excretion of 5-HIAA []

2. Plasma Chromogranin A []

Secondary Outcome Measures

1. Side effects []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Health Care	London	Ontario	Canada	N6A 4V2

Sponsors and Collaborators

• University of Western Ontario, Canada

Investigators

• Principal Investigator: Stan HM Van Uum, MD, PhD, University of Western Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00227136
• Other Study ID Numbers: 5-HTPSVU
• First Posted: Sep 27, 2005
• Last Update Posted: Apr 13, 2018
• Last Verified: Jul 1, 2006

• Keywords provided by , ,: 5Hydroxytryptamine; Chromogranin A; 5HIAA; carcinoid
• Additional relevant MeSH terms: Neuroendocrine Tumors; Carcinoid Tumor; Serotonin

Study Results

No Results Posted as of Apr 13, 2018