Effectiveness of Safe Drinking Water in Treatment of Severe Acute Malnutrition (Pakistan)
1 other identifier
interventional
820
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 22, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 31, 2017
January 1, 2017
6 months
April 22, 2016
January 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery rate
the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)
5 months
Study Arms (4)
standard SAM treatment (control group)
ACTIVE COMPARATORStandard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure.
SAM treatment + flocculent-disinfectant
EXPERIMENTALStandard 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
EXPERIMENTALStandard 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
EXPERIMENTALStandard 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.
Interventions
A household level point of use water treatment of a flocculent disinfectant will be tested.
A household level point of use water treatment of a chlorine disinfectant will be tested.
A household level point of use water treatment of a ceramic water filter will be tested.
Standard CMAM treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Action Contre la Faimlead
- Johns Hopkins Universitycollaborator
Related Publications (1)
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.
PMID: 30132426DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shannon Doocy, PhD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2016
First Posted
April 26, 2016
Study Start
April 1, 2016
Primary Completion
October 1, 2016
Study Completion
March 1, 2017
Last Updated
January 31, 2017
Record last verified: 2017-01