Clinical trial NCT00934349: Study of Dry Beriberi in Mayotte, Comoro Archipelago
Official title: Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Beriberi
Keywords: Comoro Island
vit B1 intake
Thiamine status
Genetic factor
Lead sponsor: Groupe Hospitalier Sud Reunion
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients
* Native to the Comoro Archipelago (Grande Comore, Mayotte, Anjouan, Mohéli)
* Fulfilling the clinical definition of the dry beriberi.
* Both sexes.
* Older than 15 years and 3 months (limit of the paediatrics).
* Having signed and whose legal representatives signed the form of assent, having understood the information.
* Benefiting from a social coverage regime.
* Controls
* Native to the Comoro Archipelago.
* People living in the same household as the patient, sharing the same meals.
* Both sexes.
* Older than 15 years old and 3 months.
* Free from beriberi.
* With normal neurological examination.
* Having signed and whose legal representatives signed the form of assent, having understood the information.
* Benefiting from a social coverage regime.

Exclusion Criteria:

* Aged under 15-year-old and 3 months.
* For the patients and the witnesses, the presence of pathologies known to increase needs in vitamin B1 (cancer, infectious diseases, fever, hyperthyroïdism, chronic alcoholism).

Primary outcomes:
measure: 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).
timeFrame: day 1
Secondary outcomes:
measure: To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols).
timeFrame: day 1
measure: To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect)
timeFrame: day 1
Other outcomes:
Locations:
city: Mamudzu
country: France
facility: Central Hospital - MAYOTTE
Study officials:
affiliation: Regional Hospital La Reunion - CIC-EC
name: ERIC DOUSSIET, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CENTRAL HOSPITAL MAYOTTE
name: IAN PERINET, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CENTRAL HOSPITAL MAYOTTE
name: JULIETTE WOESSNER, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Hospital La Reunion - GHSR
name: Francoise DARCEL, PHD
role: STUDY_DIRECTOR
References: