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Status unknownNCT00934349MABECOUpdated Jul 8, 2009

Study of Dry Beriberi in Mayotte, Comoro Archipelago

An observational study in Dry Beriberi, sponsored by Groupe Hospitalier Sud Reunion. Status unknown at 1 site in France. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-08.

Sponsored by Groupe Hospitalier Sud Reunion · Observational

The sponsor has not verified this record recently (last verified Jul 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dry Beriberi

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Keywords

  • Comoro Island
  • vit B1 intake
  • Thiamine status
  • Genetic factor
03

In context

Beriberi

11 studies on the registry are indexed under Beriberi; none are open to participants now.

Browse Beriberi studies →

Lead sponsor

This is the only study on the registry with Groupe Hospitalier Sud Reunion as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols).

    Time frame: day 1

  2. To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect)

    Time frame: day 1

07

Study locations

1 of 1 sites recruiting
  • Central Hospital - MAYOTTE
    Mamudzu, 97600, France
    Recruiting
    • Francois PETTINELLI, PHD · Contactfpettinelli.labo@wanado.fr
    • Ian PERINET, PHD · Sub investigator
    • Juliette WOESSNER, PHD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00934349
Lead sponsor
Groupe Hospitalier Sud Reunion
First posted
Jul 8, 2009
Start date
Jun 2009
Last update
Jul 8, 2009

Study contacts

FRANCOISE DARCEL, PHD
Contact
francoise.darcel@chr-reunion.fr
+262 262 359 166
Liliane COTTE
Contact
liliane.cotte@chr-reunion.fr
+262 692 267 675
ERIC DOUSSIET, PHD
principal investigator · Regional Hospital La Reunion - CIC-EC
IAN PERINET, PHD
principal investigator · CENTRAL HOSPITAL MAYOTTE
JULIETTE WOESSNER, PHD
principal investigator · CENTRAL HOSPITAL MAYOTTE
Francoise DARCEL, PHD
study director · Regional Hospital La Reunion - GHSR

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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