Dry BeriberiMABECONCT00934349
Study of Dry Beriberi in Mayotte, Comoro Archipelago
An observational study of Dry Beriberi, run by Groupe Hospitalier Sud Reunion at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Beriberi
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Central Hospital - MAYOTTE
Mamudzu, 97600
Francois PETTINELLI, PHD, fpettinelli.labo@wanado.fr
Ian PERINET, PHD
About this study
Official title: Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).
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.
Read the 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.
- Conditions
- Dry Beriberi
- Keywords
- Comoro Island, vit B1 intake, Thiamine status, Genetic factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 1
Secondary outcomes (2)
To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols).
Measured: day 1
To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry BeriberiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Sud Reunion
- Sponsor type
- University, hospital or other
- Investigators
- ERIC DOUSSIET, PHD, Principal investigator, Regional Hospital La Reunion - CIC-ECIAN PERINET, PHD, Principal investigator, CENTRAL HOSPITAL MAYOTTEJULIETTE WOESSNER, PHD, Principal investigator, CENTRAL HOSPITAL MAYOTTEFrancoise DARCEL, PHD, Study director, Regional Hospital La Reunion - GHSR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934349
- Sponsor's protocol ID
- 2009-A00348-49
- Other IDs
- CHR-GHSR_2009-03/01
- Acronym
- MABECO
- Status last verified
- Jul 2009
- First submitted
- 2 Jul 2009
- Last updated
- 8 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Study of Dry Beriberi in Patients Native to the Comoro Archipelago, in Mayotte (MABECO).
- ClinicalTrials.gov ID
- NCT00934349
- Acronym / sponsor ID
- MABECO / 2009-A00348-49
- Conditions
- Dry Beriberi
- Keywords
- Comoro Island, vit B1 intake, Thiamine status, Genetic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Sud ReunionUniversity, hospital or other
- Study start
- Jun 2009
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
To evaluate food intakes in vitamin B1 and anti-thiamine factors (polyphenols).
Time frame: day 1
To evaluate Thiamine biological status (blood thiamine, erythrocyte transketolase activity and the thiamine pyrophosphate effect)
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERIC DOUSSIET, PHD principal investigator
Regional Hospital La Reunion - CIC-EC
IAN PERINET, PHD principal investigator
CENTRAL HOSPITAL MAYOTTE
JULIETTE WOESSNER, PHD principal investigator
CENTRAL HOSPITAL MAYOTTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Beriberi, run by Groupe Hospitalier Sud Reunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FRANCOISE DARCEL, PHD (+262 262 359 166, francoise.darcel@chr-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.