Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001918
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
L-5-HTP-Related EMS
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
L-5-Hydroxy-Tryptophan-Related Eosinophilia-Myalgia Syndrome EMS Clinical Patient Evaluation
Status:
COMPLETED
Status Verified Date:
1999-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-M-0136 | None | None | None |