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Clinical Trials/NCT00227136
NCT00227136TerminatedPhase 3

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

University of Western Ontario, Canada2 sites in 1 country8 target enrollmentStarted: May 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Enrollment
8
Locations
2
Primary Endpoint
Urinary excretion of 5-HIAA
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Diagnostic
Masking
Double

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Urinary excretion of 5-HIAA

Plasma Chromogranin A

Secondary Outcomes

  • Side effects

Investigators

Sponsor
University of Western Ontario, Canada
Sponsor Class
Other

Study Sites (2)

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