NCT00934349

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2009

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

First QC Date

July 2, 2009

Last Update Submit

July 7, 2009

Conditions

Dry Beriberi

Keywords

Comoro Islandvit B1 intakeThiamine statusGenetic factor

Outcome Measures

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).

    day 1

Secondary Outcomes (2)

  • 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

Study Arms (2)

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.

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital - MAYOTTE

Mamudzu, 97600, France

RECRUITING

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

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Francoise DARCEL, PHD

    Regional Hospital La Reunion - GHSR

    STUDY DIRECTOR

Central Study Contacts

FRANCOISE DARCEL, PHD

CONTACT

+262 262 359 166francoise.darcel@chr-reunion.fr

Liliane COTTE

CONTACT

+262 692 267 675liliane.cotte@chr-reunion.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 8, 2009

Study Start

June 1, 2009

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations

FR(1)