Study of Dry Beriberi in Mayotte, Comoro Archipelago (MABECO)
Recruitment status was Recruiting
The purpose of this study is to assess the existence of a genetic factor, suspected to be involved, aside from likely food deficiency contribution, in occurrence of dry beriberi, in patients who experienced dry beriberi and in a case group composed of 3 people, free from beriberi, within the same household.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).|
- 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 ] [ Designated as safety issue: No ]
- To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols). [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood samples drawn for thiamine status, vit B1 dosage will be centrifuged and a serum sample will be frozen at -20°C, transferred to Regional Hospital of Reunion Island - GHSR and retained in virology laboratory of Dr MICHAULT after end of study for further explorations on beriberi
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|