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

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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