L-5-HTP-Related EMS
Primary Purpose
Eosinophilia-Myalgia Syndrome
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Eosinophilia-Myalgia Syndrome focused on measuring Cognitive Function, Depression, EMG, Eosinophilia Myalgia Syndrome, Impurities, L-5-HTP, Memory Impairment, Nerve-Muscle Biopsy, Sleep Disorders
Eligibility Criteria
Patients must be at least 18 years of age. Patients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP. Subjects will be defined as having 5-L-HTP related EMS according to the diagnostic criteria originally established by the CDC for diagnosis of L-tyrptophan-related EMS.
Sites / Locations
- National Institute of Mental Health (NIMH)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001918
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00001918
Brief Title
L-5-HTP-Related EMS
Official Title
L-5-Hydroxy-Tryptophan-Related Eosinophilia-Myalgia Syndrome (EMS): Clinical Patient Evaluation
Study Type
Observational
2. Study Status
Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief 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.
Detailed Description
The L-tryptophan-related eosinophilia myalgia syndrome (EMS), characterized by eosinophilia, myalgias, myositis, scleroderma-like skin fibrosis and fasciitis, occurred in 1989 in over 1500 patients who had ingested L-tryptophan for sleep disturbances and depression. The identical clinical syndrome has also occurred in subjects ingesting L-5-hydroxytryptophan (L-5-HTP).
Recently, a letter to Nature Medicine reported the presence of an impurity in 6 out of 6 samples of L-5-HTP obtained randomly at health food stores. This impurity appears to be the same as the one identified in material ingested by a family (mother and 2 babies) who had developed an EMS-like syndrome after ingesting L-5-HTP.
Although there have been no definite new cases of L-5-HTP-related EMS, the FDA is currently investigating unconfirmed reports of possible new cases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilia-Myalgia Syndrome
Keywords
Cognitive Function, Depression, EMG, Eosinophilia Myalgia Syndrome, Impurities, L-5-HTP, Memory Impairment, Nerve-Muscle Biopsy, Sleep Disorders
7. Study Design
Enrollment
20 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must be at least 18 years of age.
Patients newly diagnosed with eosinophilia and myalgia, and who ingested L-5-HTP.
Subjects will be defined as having 5-L-HTP related EMS according to the diagnostic criteria originally established by the CDC for diagnosis of L-tyrptophan-related EMS.
Facility Information:
Facility Name
National Institute of Mental Health (NIMH)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
1690352
Citation
Silver RM, Heyes MP, Maize JC, Quearry B, Vionnet-Fuasset M, Sternberg EM. Scleroderma, fasciitis, and eosinophilia associated with the ingestion of tryptophan. N Engl J Med. 1990 Mar 29;322(13):874-81. doi: 10.1056/NEJM199003293221302.
Results Reference
background
PubMed Identifier
1727200
Citation
Kamb ML, Murphy JJ, Jones JL, Caston JC, Nederlof K, Horney LF, Swygert LA, Falk H, Kilbourne EM. Eosinophilia-myalgia syndrome in L-tryptophan-exposed patients. JAMA. 1992 Jan 1;267(1):77-82. doi: 10.1001/jama.267.1.77.
Results Reference
background
PubMed Identifier
1969024
Citation
Eidson M, Philen RM, Sewell CM, Voorhees R, Kilbourne EM. L-tryptophan and eosinophilia-myalgia syndrome in New Mexico. Lancet. 1990 Mar 17;335(8690):645-8. doi: 10.1016/0140-6736(90)90421-z.
Results Reference
background
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L-5-HTP-Related EMS
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