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

September 23, 2005
July 11, 2006
May 2005
Not Provided
  • Urinary excretion of 5-HIAA
  • Plasma Chromogranin A
Same as current
Complete list of historical versions of study NCT00227136 on ClinicalTrials.gov Archive Site
Side effects
Same as current
Not Provided
Not Provided
 
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
  • Carcinoid Tumors
  • Neuroendocrine Tumors
Drug: 5-Hydroxy-Tryptamine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
September 2005
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00227136
5-HTPSVU
Not Provided
Not Provided
University of Western Ontario, Canada
Not Provided
Principal Investigator: Stan HM Van Uum, MD, PhD University of Western Ontario, Canada
University of Western Ontario, Canada
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP