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NCT00001918 · ClinicalTrials.gov registry record
L-5-HTP-Related EMS
A clinical trial, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- 20
- Enrollment target
NCT00001918: Completed study, sponsored by National Institute of Mental Health (NIMH).
NCT00001918 is a clinical trial that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001918 has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms include fever, muscle aches and inflammation, and skin rashes. As many as 40 of the patients who became ill died. It is suspected that impurities in the supplements caused the disease. More recently, similar impurities have been detected in batches of a similar dietary supplement called L-5-hydroxytryptophan. This study is designed to learn more about EMS that develops in patients taking L-5-hydroxytryptophan. The study is open to patients newly diagnosed with eosinophilia myalgia who have taken L-5-HTP. Patients in the study will have a physical examination and urine and blood tests. They may also have X rays, an electrocardiogram, magnetic resonance imaging (MRI), and a skin test for tuberculosis. They will have a psychiatric interview, take a memory test, and fill out questionnaires relating to sadness and depression. Patients may also undergo special tests to study conduction of nerve impulses and muscle function. Samples of patients' supplements will be taken for chemical analysis.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 1999-07 |
| Est. Completion | 2000-08 |
What the finished NCT00001918 record still lists
NCT00001918 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00001918 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001918 about?
NCT00001918 is a clinical study titled "L-5-HTP-Related EMS". In 1989 more than 1500 people who took the dietary supplement L-tryptophan for insomnia and depression developed eosinophilia myalgia syndrome (EMS)-a potentially fatal disease characterized by an excess of a type of white blood cell called eosinophils. Disease symptoms include fever, muscle aches a...
What is the current status of trial NCT00001918?
This trial is currently completed. The enrollment target is 20 participants. The study started on 1999-07. Estimated completion is 2000-08.
Who is sponsoring clinical trial NCT00001918?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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