MABECO: Study of Dry Beriberi in Mayotte, Comoro Archipelago

Sponsor

Groupe Hospitalier Sud Reunion (Other)

Overall Status

Unknown status

CT.gov ID

NCT00934349

Collaborator

(none)

200

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Beriberi

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).

Study Start Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Patient Native to the Comoro Archipelago (Grande Comore, Mayotte, Anjouan, Mohéli) fulfilling the clinical definition of the dry beriberi.
Control 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.

Outcome Measures

Primary Outcome Measures

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). [day 1]

Secondary Outcome Measures

To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols). [day 1]
To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect) [day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Hospital - MAYOTTE	Mamudzu		France	97600

Sponsors and Collaborators

Groupe Hospitalier Sud Reunion

Investigators

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