Study of Dry Beriberi in Mayotte, Comoro Archipelago

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00934349

Acronym

MABECO

Enrollment

200

Registered

2009-07-08

Start date

2009-06-30

Completion date

Unknown

Last updated

2009-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Beriberi

Keywords

Comoro Island, vit B1 intake, Thiamine status, Genetic factor

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
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

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

Countries

France

Contacts

Primary ContactFRANCOISE DARCEL, PHD

francoise.darcel@chr-reunion.fr+262 262 359 166

Backup ContactLiliane COTTE

liliane.cotte@chr-reunion.fr+262 692 267 675

Outcome results