GeophagiaPrevalgeophagyNCT03948126
Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France
An observational study of Geophagia, run by CHU de Reims at 1 site in France.
Trial summary
Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Geophagia
- What is being tested?
- Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)
- Type of treatment
- Vaccines
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2015to 1 Sep 2016
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and attending a travel medicine and international vaccination consultation in France.
inclusion criteria : All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries
Trial locations and contacts
1 site in 1 country.
About this study
Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.
Read the detailed description
Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.
A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries were eligible to complete a confidential questionnaire about geophagy, which was defined as eating soil or clay. Descriptive analysis was performed.
- Conditions
- Geophagia
- Being tested
- Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)
- Keywords
- geophagia
- Medical subject headings
- Pica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)Other
| Study group | Role | What they receive |
|---|---|---|
| travel medicine | Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and attending a travel medicine and international vaccination consultation in France. Receives: Other: Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of geophagia
percentage of adults with geophagia
Measured: Day 0
Secondary outcomes (4)
Awareness about iron-deficient anaemia
percentage of awareness about iron-deficient anaemia
Measured: Day 0
Awareness about soil-transmitted intestinal parasitic infections
percentage of awareness about soil-transmitted intestinal parasitic infections
Measured: Day 0
Awareness about constipation
percentage of awareness about constipation
Measured: Day 0
Awareness about intestinal occlusion
percentage of awareness about intestinal occlusion
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Apr 2015
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GeophagiaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948126
- Sponsor's protocol ID
- 2018Ao007
- Acronym
- Prevalgeophagy
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.
PubMed 30547293
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Geophagy and Knowledge About Its Health Effects Among Native Sub-Saharan Africa, Caribbean and South America Healthy Adults Living in France
- ClinicalTrials.gov ID
- NCT03948126
- Acronym / sponsor ID
- Prevalgeophagy / 2018Ao007
- Conditions
- Geophagia
- Keywords
- geophagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 13 May 2019 (actual)
- 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.
Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.
Detailed description
Since geophagy is widespread among women from Sub-Saharan Africa, South America and the Caribbean, we aimed to determine the frequency of geophagy and the level of knowledge about its health effects among healthy adults originating from these countries and attending a travel medicine and international vaccination consultation in France.
A cross-sectional study was performed in the consultation for travel medicine and international vaccination in Reims University Hospital, France. All adult travellers who were natives of Sub Saharan Africa, South America and the Caribbean or born in France of parents from these countries were eligible to complete a confidential questionnaire about geophagy, which was defined as eating soil or clay. Descriptive analysis was performed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| travel medicine | – | Other: Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and attending a travel medicine and international vaccination consultation in France. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults originating from Sub-Saharan Africa, South America and the Caribbean and attending a travel medicine and international vaccination consultation in France.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy) | Other | travel medicine |
Primary outcome
Prevalence of geophagia
Time frame: Day 0
percentage of adults with geophagia
4 secondary outcomes
Awareness about iron-deficient anaemia
Time frame: Day 0
Awareness about soil-transmitted intestinal parasitic infections
Time frame: Day 0
Awareness about constipation
Time frame: Day 0
Awareness about intestinal occlusion
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Background: PubMed 30547293Decaudin P, Kanagaratnam L, Kmiec I, Nguyen Y, Migault C, Lebrun D, Hentzien M, Bertin E, Drame M, Bani-Sadr F. Prevalence of geophagy and knowledge about its health effects among native Sub-Saharan Africa, Caribbean and South America healthy adults living in France. Eat Weight Disord. 2020 Apr;25(2):465-469. doi: 10.1007/s40519-018-0624-9. Epub 2018 Dec 13.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Geophagia, run by CHU de Reims 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?
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: finished, as of the sponsor's last update on 13 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of geophagia (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03948126, which also lists 1 linked publication.
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 13 May 2019.