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.

Intervention / Treatment

  • 5-Hydroxy-Tryptamine (DRUG)
    N/A

Condition or Disease

  • Carcinoid Tumors
  • Neuroendocrine Tumors

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 8 ()
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Diagnostic

    Masking

    Clinical Trial Dates

    Start date: May 01, 2005
    Completion Date: Sep 01, 2005
    Study First Posted: Sep 27, 2005 ESTIMATED
    Last Updated: Apr 11, 2018

    Sponsors / Collaborators

    Responsible Party: N/A
    No responsible party listed

    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 Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Urinary excretion of 5-HIAA
    • Plasma Chromogranin A
    Secondary Outcomes
    • Side effects

    More Details

    NCT Number: NCT00227136
    Other IDs: 5-HTPSVU
    Study URL: https://clinicaltrials.gov/study/NCT00227136
    Last updated: Sep 29, 2023