Study of Dry Beriberi in Mayotte, Comoro Archipelago (MABECO)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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). |
- 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 ]
- 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 |
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
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| 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 | |
| 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 | |
| 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 May 19, 2013