Study of Dry Beriberi in Mayotte, Comoro Archipelago (MABECO)
Recruitment status was Recruiting
|First Received Date ICMJE||July 2, 2009|
|Last Updated Date||July 7, 2009|
|Start Date ICMJE||June 2009|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00934349 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of Dry Beriberi in Mayotte, Comoro Archipelago|
|Official Title ICMJE||Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).|
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.
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 ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|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
|Sampling Method||Probability Sample|
Patients Native to the Comoro Archipelago (Grande Comore, Mayotte, Anjouan, Mohéli) fulfilling the clinical definition of the dry beriberi. 3 controls fullfilling inclusion criteria will be recruited within the houshold by drawing lots.among
|Condition ICMJE||Dry Beriberi|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||200|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||15 Years and older|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00934349|
|Other Study ID Numbers ICMJE||2009-A00348-49, CHR-GHSR_2009-03/01|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Joaquin MARTINEZ / Clinical Research and Innovation Director, Regional Hospital, Reunion Island|
|Study Sponsor ICMJE||Groupe Hospitalier Sud Reunion|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Groupe Hospitalier Sud Reunion|
|Verification Date||July 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP