Study of Dry Beriberi in Mayotte, Comoro Archipelago (MABECO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00934349|
Recruitment Status : Unknown
Verified July 2009 by Groupe Hospitalier Sud Reunion.
Recruitment status was: Recruiting
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
|Condition or disease|
A team of 2 investigators, a nurse and an investigator speaking French, Shibushi and Shimaore (3 languages in use in Mayotte), will visit exposed patients who agreed to participate to the study.
3 controls, fulfilling inclusion criteria, will be recruited within the household by drawing lots.
Clinical examination and food survey by means of a questionnaire will be performed.
Blood samples will be drawn to determine thiamine status, vitamin B1 dosage, erythrocyte transketolase activity and thiamine pyrophosphate effect, analysis will be performed by Biomnis laboratory in Lyon.
For the genetic study, 4 drops of blood will be put down on Whatman paper and sent to Dr Johannes COY in Darmstadt Germany, for DNA extraction and PCR screening for mutations.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).|
|Study Start Date :||June 2009|
Native to the Comoro Archipelago (Grande Comore, Mayotte, Anjouan, Mohéli) fulfilling the clinical definition of the dry beriberi.
Native to the Comoro Archipelago, living in the same household as the patient, sharing the same meals. Free from beriberi and with normal neurological examination.
- Mutations on one of the alleles of the promoter of the gene TKTL1 (transketolase-like gene) in the homozygous state in the patients and not in the controls (heterozygotes or not carrier of the mutation). [ Time Frame: day 1 ]
- To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols). [ Time Frame: day 1 ]
- To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect) [ Time Frame: day 1 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934349
|Contact: FRANCOISE DARCEL, PHD||+262 262 359 email@example.com|
|Contact: Liliane COTTE||+262 692 267 firstname.lastname@example.org|
|Central Hospital - MAYOTTE||Recruiting|
|Mamudzu, France, 97600|
|Contact: Francois PETTINELLI, PHD email@example.com|
|Sub-Investigator: Ian PERINET, PHD|
|Sub-Investigator: Juliette WOESSNER, PHD|
|Principal Investigator:||ERIC DOUSSIET, PHD||Regional Hospital La Reunion - CIC-EC|
|Principal Investigator:||IAN PERINET, PHD||CENTRAL HOSPITAL MAYOTTE|
|Principal Investigator:||JULIETTE WOESSNER, PHD||CENTRAL HOSPITAL MAYOTTE|
|Study Director:||Francoise DARCEL, PHD||Regional Hospital La Reunion - GHSR|