Lead PoisoningNCT05265572
Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
A study testing Domestic Hygiene and household hygiene Intervention in people with Lead Poisoning and Lead Poison Children, run by University of Johannesburg at 1 site in South Africa.
Trial summary
The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Lead Poisoning, Lead Poison Children
- What is being tested?
- Domestic Hygiene and household hygiene Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Sep 2021to 30 Sep 2022
- Phase
- Interventional
- 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 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between the ages of one and five years
Who cannot join
- Children above 5 years
Trial locations and contacts
1 site in 1 country.
About this study
The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.
Read the detailed description
A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.
- Conditions
- Lead Poisoning, Lead Poison Children
- Being tested
- Domestic Hygiene and household hygiene Intervention
- Keywords
- Lead, Lead exposure, Mine Dumps
- Medical subject headings
- Lead Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Domestic Hygiene and household hygiene InterventionBehavioural
A demonstration on the domestic hygiene intervention will be conducted where participants will be guided on optimal cleaning of windowsills, floors and other surfaces with water and detergent, and advised on appropriate method of cleaning. Participants will be provided with a package of cleaning materials (mop, bucket, detergent, hand wash liquid soap and cloth for wet dusting) which will be used during the demonstration, and retained by participants to facilitate sustainability of the intervention during and after the study. Participants will be further engaged in an educational discussion, with the aid of a specially designed educational pamphlet containing information about health effects potentially associated with dust lead exposure from mine dumps and the personal hygiene and domestic hygiene steps that may be followed to reduce dust lead exposure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The group that will receive the intervention to apply Receives: Behavioral: Domestic Hygiene and household hygiene Intervention |
| Control group | No intervention | The group that will not receive the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead exposure level
To detect a mean difference in change from baseline to follow-up of -0.5 μg/dL between the control and experimental group, with common standard deviation of 2 μg/dL
Measured: Three months
Secondary outcomes (1)
Reference Lead exposure level
A reference level of 5.0 μg/dL for public health intervention of exposure to lead
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start14 Sep 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
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 Lead PoisoningStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are divided into two groups and one group is assigned to one household hygiene and an educational intervention which they apply and the impact of the intervention on lead exposure is assessed and the other group has no intervention.
- Masking
- None (open label)
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Johannesburg
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Principal investigator, Charlotte Mokoatle, University of Johannesburg
- Investigators
- Makhutsisa C Mokoatle, Masters, Principal investigator, University of JohannesburgVusumuzi Nkosi, PhD, Study director, Medical Research Council, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265572
- Sponsor's protocol ID
- Mining Intervention Study
- Status last verified
- Apr 2022
- First submitted
- 18 Feb 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IDP to be shared
Publications
Mokoatle C, Mathee A, Street R, Nkosi V. A study protocol to evaluate the impact of a personal and domestic hygiene intervention on lead exposure in a community next to a mine dump. BMC Public Health. 2022 Jun 4;22(1):1123. doi: 10.1186/s12889-022-13439-8.
PubMed 35658916
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Personal and Domestic Hygiene Intervention on Lead Exposure in a Community Close to a Mine Dump
- ClinicalTrials.gov ID
- NCT05265572
- Acronym / sponsor ID
- Mining Intervention Study
- Conditions
- Lead Poisoning, Lead Poison Children
- Keywords
- Lead, Lead exposure, Mine Dumps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- University of JohannesburgUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 3 Mar 2022 (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.
The study evaluates the impact of a personal and domestic hygiene intervention on exposure to lead in a community close to a mine dump. A before and after intervention study will be conducted in a selected area to determine lead exposure levels and the reduction or not after application of the intervention.
Detailed description
A before and after intervention study will be conducted with a control and intervention group, where data will be collected at the household (through questionnaire based interviews, floor and/or windowsill samples and soil samples collection) and individual level (through hand dust wipe sample collection). In phase one, both the control and intervention group will be interviewed, household floor and/or windowsill dust wipes will be taken, yard soil sample collected and hand dust wipe samples will be taken from children in participating households. After baseline data collection, participants will be allocated into either intervention or control group. The intervention group will participate in the domestic hygiene demonstration and educational discussion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are divided into two groups and one group is assigned to one household hygiene and an educational intervention which they apply and the impact of the intervention on lead exposure is assessed and the other group has no intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Domestic Hygiene and household hygiene InterventionThe group that will receive the intervention to apply |
| Control group | No intervention | –The group that will not receive the intervention |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of one and five years
Key exclusion criteria (1 listed)
- Children above 5 years
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 |
|---|---|---|
| Domestic Hygiene and household hygiene InterventionA demonstration on the domestic hygiene intervention will be conducted where participants will be guided on optimal cleaning of windowsills, floors and other surfaces with water and detergent, and advised on appropriate method of cleaning. Participants will be provided with a package of cleaning materials (mop, bucket, detergent, hand wash liquid soap and cloth for wet dusting) which will be used during the demonstration, and retained by participants to facilitate sustainability of the intervention during and after the study. Participants will be further engaged in an educational discussion, with the aid of a specially designed educational pamphlet containing information about health effects potentially associated with dust lead exposure from mine dumps and the personal hygiene and domestic hygiene steps that may be followed to reduce dust lead exposure. | Behavioural | Intervention group |
Primary outcome
Lead exposure level
Time frame: Three months
To detect a mean difference in change from baseline to follow-up of -0.5 μg/dL between the control and experimental group, with common standard deviation of 2 μg/dL
1 secondary outcome
Reference Lead exposure level
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 35658916Mokoatle C, Mathee A, Street R, Nkosi V. A study protocol to evaluate the impact of a personal and domestic hygiene intervention on lead exposure in a community next to a mine dump. BMC Public Health. 2022 Jun 4;22(1):1123. doi: 10.1186/s12889-022-13439-8.
- Individual participant dataSharing planned: Yes. All collected IDP to be shared
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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.
Makhutsisa C Mokoatle, Masters principal investigator
University of Johannesburg
Vusumuzi Nkosi, PhD study director
Medical Research Council, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Domestic Hygiene and household hygiene Intervention in people with Lead Poisoning and Lead Poison Children, run by University of Johannesburg at 1 site in South Africa.
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 1 inclusion and 1 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 11 Apr 2022. 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 South Africa. 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?
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?
Lead exposure level (time frame: Three months). 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 NCT05265572, 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 11 Apr 2022.