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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Groupe Hospitalier Sud Reunion.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Groupe Hospitalier Sud Reunion
ClinicalTrials.gov Identifier:
NCT00934349
First received: July 2, 2009
Last updated: July 7, 2009
Last verified: July 2009

July 2, 2009
July 7, 2009
June 2009
Not Provided
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00934349 on ClinicalTrials.gov Archive Site
  • To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols). [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Dry Beriberi in Mayotte, Comoro Archipelago
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood samples drawn for thiamine status, vit B1 dosage will be centrifuged and a serum sample will be frozen at -20°C, transferred to Regional Hospital of Reunion Island - GHSR and retained in virology laboratory of Dr MICHAULT after end of study for further explorations on beriberi

Probability Sample

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

Dry Beriberi
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

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).
Both
15 Years and older
Yes
Contact: FRANCOISE DARCEL, PHD +262 262 359 166 francoise.darcel@chr-reunion.fr
Contact: Liliane COTTE +262 692 267 675 liliane.cotte@chr-reunion.fr
France
 
NCT00934349
2009-A00348-49, CHR-GHSR_2009-03/01
Yes
Joaquin MARTINEZ / Clinical Research and Innovation Director, Regional Hospital, Reunion Island
Groupe Hospitalier Sud Reunion
Not Provided
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
Groupe Hospitalier Sud Reunion
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP