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

This study has been terminated.
Sponsor:
Information provided by:
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00227136
First received: September 23, 2005
Last updated: July 11, 2006
Last verified: July 2006
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00227136     History of Changes
Other Study ID Numbers: 5-HTPSVU
Study First Received: September 23, 2005
Last Updated: July 11, 2006
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on July 10, 2014