Brief Title
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
Official Title
Effect of Oral 5-HTP Intake on Urinary 5-HIAA Excretion
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Urinary excretion of 5-HIAA
Secondary Outcome
Side effects
Condition
Carcinoid Tumors
Intervention
5-Hydroxy-Tryptamine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
8
Start Date
May 2005
Completion Date
September 2005
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Stan HM Van Uum, MD, PhD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT00227136
Organization ID
5-HTPSVU
Study Sponsor
University of Western Ontario, Canada
Study Sponsor
Stan HM Van Uum, MD, PhD, Principal Investigator, University of Western Ontario, Canada
Verification Date
July 2006