Study of Dry Beriberi in Mayotte, Comoro Archipelago | NCT00934349

Studies
Study of Dry Beriberi in Mayotte, Comoro Archipelago

NCT00934349

Sponsor

Groupe Hospitalier Sud Reunion

Status

Unknown status

Last Update Posted

Jul 8, 2009Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Dry Beriberi

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CHR-GHSR_2009-03/01

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 2, 2009

First Submission Date that Met QC Criteria

Jul 7, 2009

First Posted Date

Jul 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2009

Last Update Posted Date

Jul 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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).		day 1

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
FRANCOISE DARCEL, PHD	Contact	+262 262 359 166		francoise.darcel@chr-reunion.fr
Liliane COTTE	Contact	+262 692 267 675		liliane.cotte@chr-reunion.fr

Overall Officials

Name	Affiliation	Role
ERIC DOUSSIET, PHD	Regional Hospital La Reunion - CIC-EC	Principal Investigator
IAN PERINET, PHD	CENTRAL HOSPITAL MAYOTTE	Principal Investigator
JULIETTE WOESSNER, PHD

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Hospital - MAYOTTE	Recruiting	Mamudzu		97600	France