UnknownNot Applicable

Study of Dry Beriberi in Mayotte, Comoro Archipelago

France200 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Timeframe: day 1

Trial details

NCT IDNCT00934349

SponsorGroupe Hospitalier Sud Reunion

Sponsor typeOTHER

Study typeOBSERVATIONAL

Contact for this trial

FRANCOISE DARCEL, PHD

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

View on ClinicalTrials.gov More Dry Beriberi trials