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
  Purpose

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
Dry Beriberi

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Sud Reunion:

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). [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 200
Study Start Date: June 2009
Groups/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.

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934349

Contacts
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

Locations
France
Central Hospital - MAYOTTE Recruiting
Mamudzu, France, 97600
Contact: Francois PETTINELLI, PHD       fpettinelli.labo@wanado.fr   
Sub-Investigator: Ian PERINET, PHD         
Sub-Investigator: Juliette WOESSNER, PHD         
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
  More Information

No publications provided

Responsible Party: Joaquin MARTINEZ / Clinical Research and Innovation Director, Regional Hospital, Reunion Island
ClinicalTrials.gov Identifier: NCT00934349     History of Changes
Other Study ID Numbers: 2009-A00348-49, CHR-GHSR_2009-03/01
Study First Received: July 2, 2009
Last Updated: July 7, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Hospitalier Sud Reunion:
Comoro Island
vit B1 intake
Thiamine status
Genetic factor

Additional relevant MeSH terms:
Beriberi
Thiamine Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 20, 2014