MarasmusNCT02751476
Effectiveness of Safe Drinking Water in Treatment of Severe Acute Malnutrition (Pakistan)
A study testing Point of Use (PoU) water treatment flocculent disinfectant., Point of Use (PoU) water treatment chlorine disinfectant and Point of Use (PoU) ceramic water filter in people with Marasmus, run by Action Contre la Faim.
Trial summary
This study builds evidence on the importance of using safe drinking water during the nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce exposure to pathogens that cause diarrhoeal… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Marasmus
- What is being tested?
- Point of Use (PoU) water treatment flocculent disinfectant., Point of Use (PoU) water treatment chlorine disinfectant and Point of Use (PoU) ceramic water filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 820 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Mar 2017
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children in each selected community will be eligible for inclusion in the study if they are
- between six and 59 months of age,
- diagnosed as an uncomplicated SAM case
- enrolled in ACF's CMAMprogram
- if the child's caretaker gives consent for the child's participation.
Who cannot join
- Children will be ineligible for participation if
- they have a diagnosis of kwashiorkor; OR 2) they require in-patient treatment for SAM
- their caretakers are unwilling or unable to agree to their participation.
- Children graduating from in-patient treatment (i.e no remaining medical complications) to the out-patient CMAM program will be eligible for participation.
About this study
Official title: Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition
This study builds evidence on the importance of using safe drinking water during the nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness of safe drinking water in reducing SAM treatment cost and duration and will provide recommendations for improving SAM treatment protocols.
Read the detailed description
A four group randomized control trial (RCT) will be used to evaluate the effectiveness of safe drinking water in SAM treatment protocols. Intervention groups will include: 1) standard SAM treatment (control group); 2) standard SAM treatment + flocculent-disinfectant water treatment (P\&G Purifier of Water); 3) standard SAM treatment + chlorine disinfectant ("Aquatabs", a locally available mass market product); and 4) standard SAM treatment + ceramic water filter (locally available mass market product). All intervention groups will receive the standard SAM nutrition treatment and hygiene education. The control group will receive standard Community Managed Acute Malnutrition (CMAM) treatment only and households will use existing water treatment methods to represent the conventional CMAM program and to enable comparison with the other study arms (with improved water provision methods). A RCT was identified because it is a rigorous gold standard methodology design that is feasible given the context, and appropriate for determining whether or not safe drinking water is effective in CMAM programs. Site level randomization will be used and is preferable to individual randomization from a management perspective and because it increases likelihood of fidelity to the planned intervention. Limitations of the proposed design include 1) potential for bias because the study is not blinded and 2) possible contamination of the comparison groups. In order to minimize these risks, efforts will be made to geographically separate the comparison groups to reduce the risk of sharing of water treatment products. Blinding is not possible given the obviously different nature of the three PoU water treatment approaches and the need for a control group.
- Conditions
- Marasmus
- Being tested
- Point of Use (PoU) water treatment flocculent disinfectant., Point of Use (PoU) water treatment chlorine disinfectant, Point of Use (PoU) ceramic water filter, Standard Severe Acute Malnutrition Treatment
- Medical subject headings
- Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Use (PoU) water treatment flocculent disinfectant.Other
A household level point of use water treatment of a flocculent disinfectant will be tested.
Point of Use (PoU) water treatment chlorine disinfectantOther
A household level point of use water treatment of a chlorine disinfectant will be tested.
Point of Use (PoU) ceramic water filterDevice
A household level point of use water treatment of a ceramic water filter will be tested.
Standard Severe Acute Malnutrition TreatmentOther
Standard CMAM treatment.
| Study group | Role | What they receive |
|---|---|---|
| standard SAM treatment (control group) | Active comparator | Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. Receives: Other: Standard Severe Acute Malnutrition Treatment |
| SAM treatment + flocculent-disinfectant | Experimental | Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a flocculent-disinfectant for household level application. Receives: Other: Point of Use (PoU) water treatment flocculent disinfectant.; Other: Standard Severe Acute Malnutrition Treatment |
| SAM treatment + chlorine disinfectant | Experimental | Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a chlorine disinfectant for household level application. Receives: Other: Point of Use (PoU) water treatment chlorine disinfectant; Other: Standard Severe Acute Malnutrition Treatment |
| SAM treatment + ceramic water filter | Experimental | Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a ceramic water filter for household level application. Receives: Device: Point of Use (PoU) ceramic water filter; Other: Standard Severe Acute Malnutrition Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate
the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionMar 2017 (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 MarasmusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 820 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Contre la Faim
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Shannon Doocy, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751476
- Sponsor's protocol ID
- PKG1A
- Status last verified
- Jan 2017
- First submitted
- 22 Apr 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Doocy S, Tappis H, Villeminot N, Suk A, Kumar D, Fazal S, Grant A, Pietzsch S. Point-of-use water treatment improves recovery rates among children with severe acute malnutrition in Pakistan: results from a site-randomized trial. Public Health Nutr. 2018 Nov;21(16):3080-3090. doi: 10.1017/S1368980018001647. Epub 2018 Aug 22.
PubMed 30132426
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT02751476
- Acronym / sponsor ID
- PKG1A
- Conditions
- Marasmus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 820 participants (estimated)
- Lead sponsor
- Action Contre la FaimUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 26 Apr 2016 (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.
This study builds evidence on the importance of using safe drinking water during the nutritional treatment of children affected by Severe Acute Malnutrition (SAM). The following hypotheses will be tested: 1.The addition of safe drinking water to SAM treatment will reduce exposure to pathogens that cause diarrhoeal disease, thereby reducing diarrhoea incidence among enrolled children. 2.Reductions in pathogen exposure and diarrhoeal disease will result in shorter recovery pe-riods for children with SAM. The study will evaluate the effectiveness of safe drinking water in reducing SAM treatment cost and duration and will provide recommendations for improving SAM treatment protocols.
Detailed description
A four group randomized control trial (RCT) will be used to evaluate the effectiveness of safe drinking water in SAM treatment protocols. Intervention groups will include: 1) standard SAM treatment (control group); 2) standard SAM treatment + flocculent-disinfectant water treatment (P\&G Purifier of Water); 3) standard SAM treatment + chlorine disinfectant ("Aquatabs", a locally available mass market product); and 4) standard SAM treatment + ceramic water filter (locally available mass market product). All intervention groups will receive the standard SAM nutrition treatment and hygiene education. The control group will receive standard Community Managed Acute Malnutrition (CMAM) treatment only and households will use existing water treatment methods to represent the conventional CMAM program and to enable comparison with the other study arms (with improved water provision methods). A RCT was identified because it is a rigorous gold standard methodology design that is feasible given the context, and appropriate for determining whether or not safe drinking water is effective in CMAM programs. Site level randomization will be used and is preferable to individual randomization from a management perspective and because it increases likelihood of fidelity to the planned intervention. Limitations of the proposed design include 1) potential for bias because the study is not blinded and 2) possible contamination of the comparison groups. In order to minimize these risks, efforts will be made to geographically separate the comparison groups to reduce the risk of sharing of water treatment products. Blinding is not possible given the obviously different nature of the three PoU water treatment approaches and the need for a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| standard SAM treatment (control group) | Active comparator | Other: Standard Severe Acute Malnutrition TreatmentStandard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. |
| SAM treatment + flocculent-disinfectant | Experimental | Other: Point of Use (PoU) water treatment flocculent disinfectant., Other: Standard Severe Acute Malnutrition TreatmentStandard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a flocculent-disinfectant for household level application. |
| SAM treatment + chlorine disinfectant | Experimental | Other: Point of Use (PoU) water treatment chlorine disinfectant, Other: Standard Severe Acute Malnutrition TreatmentStandard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a chlorine disinfectant for household level application. |
| SAM treatment + ceramic water filter | Experimental | Device: Point of Use (PoU) ceramic water filter, Other: Standard Severe Acute Malnutrition TreatmentStandard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure. In addition, caregivers receive a ceramic water filter for household level application. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children in each selected community will be eligible for inclusion in the study if they are
Key exclusion criteria (4 listed)
- Children will be ineligible for participation if
- Children graduating from in-patient treatment (i.e no remaining medical complications) to the out-patient CMAM program will be eligible for participation.
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 |
|---|---|---|
| Point of Use (PoU) water treatment flocculent disinfectant.A household level point of use water treatment of a flocculent disinfectant will be tested. | Other | SAM treatment + flocculent-disinfectant |
| Point of Use (PoU) water treatment chlorine disinfectantA household level point of use water treatment of a chlorine disinfectant will be tested. | Other | SAM treatment + chlorine disinfectant |
| Point of Use (PoU) ceramic water filterA household level point of use water treatment of a ceramic water filter will be tested. | Device | SAM treatment + ceramic water filter |
| Standard Severe Acute Malnutrition TreatmentStandard CMAM treatment. | Other | SAM treatment + ceramic water filter, SAM treatment + chlorine disinfectant, SAM treatment + flocculent-disinfectant, standard SAM treatment (control group) |
Primary outcome
Recovery rate
Time frame: 5 months
the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Derived from this study: PubMed 30132426Doocy S, Tappis H, Villeminot N, Suk A, Kumar D, Fazal S, Grant A, Pietzsch S. Point-of-use water treatment improves recovery rates among children with severe acute malnutrition in Pakistan: results from a site-randomized trial. Public Health Nutr. 2018 Nov;21(16):3080-3090. doi: 10.1017/S1368980018001647. Epub 2018 Aug 22.
- Individual participant dataSharing planned: Undecided
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.
Shannon Doocy, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Point of Use (PoU) water treatment flocculent disinfectant., Point of Use (PoU) water treatment chlorine disinfectant and Point of Use (PoU) ceramic water filter in people with Marasmus, run by Action Contre la Faim.
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 5 inclusion and 4 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Recovery rate (time frame: 5 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 NCT02751476, 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 31 Jan 2017.