Study of Dry Beriberi in Mayotte, Comoro Archipelago (MABECO)

July 7, 2009 updated by: Groupe Hospitalier Sud Réunion

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Mamudzu, France, 97600
        • Recruiting
        • Central Hospital - MAYOTTE
        • Contact:
        • Sub-Investigator:
          • Ian PERINET, PHD
        • Sub-Investigator:
          • Juliette WOESSNER, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome 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).
Time Frame: day 1
day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Sud Réunion

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Registration Dates

First Submitted

July 2, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

July 8, 2009

Last Update Submitted That Met QC Criteria

July 7, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-A00348-49
  • CHR-GHSR_2009-03/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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