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Effectiveness of Safe Drinking Water in Treatment of Severe Acute Malnutrition (Pakistan)

Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02751476
Enrollment
820
Registered
2016-04-26
Start date
2016-04-30
Completion date
2017-03-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marasmus

Brief 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 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.

Interventions

OTHERPoint of Use (PoU) water treatment flocculent disinfectant.

A household level point of use water treatment of a flocculent disinfectant will be tested.

OTHERPoint of Use (PoU) water treatment chlorine disinfectant

A household level point of use water treatment of a chlorine disinfectant will be tested.

DEVICEPoint of Use (PoU) ceramic water filter

A household level point of use water treatment of a ceramic water filter will be tested.

OTHERStandard Severe Acute Malnutrition Treatment

Standard CMAM treatment.

Sponsors

Johns Hopkins University
CollaboratorOTHER
Action Contre la Faim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

* Children in each selected community will be eligible for inclusion in the study if they are 1. between six and 59 months of age, 2. diagnosed as an uncomplicated SAM case 3. enrolled in ACF's CMAMprogram 4. if the child's caretaker gives consent for the child's participation.

Exclusion criteria

* Children will be ineligible for participation if 1. they have a diagnosis of kwashiorkor; OR 2) they require in-patient treatment for SAM 2. 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.

Design outcomes

Primary

MeasureTime frameDescription
Recovery rate5 monthsthe total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026