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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227136
First Posted: September 27, 2005
Last Update Posted: July 12, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Western Ontario, Canada
  Purpose
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 Intervention Phase
Carcinoid Tumors Neuroendocrine Tumors Drug: 5-Hydroxy-Tryptamine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • Urinary excretion of 5-HIAA
  • Plasma Chromogranin A

Secondary Outcome Measures:
  • Side effects

Estimated Enrollment: 8
Study Start Date: May 2005
Estimated Study Completion Date: September 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227136


Locations
Canada, Ontario
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
  More Information

ClinicalTrials.gov Identifier: NCT00227136     History of Changes
Other Study ID Numbers: 5-HTPSVU
First Submitted: September 23, 2005
First Posted: September 27, 2005
Last Update Posted: July 12, 2006
Last Verified: July 2006

Keywords provided by University of Western Ontario, Canada:
5Hydroxytryptamine
Chromogranin A
5HIAA
carcinoid

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs