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

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ClinicalTrials.gov Identifier: NCT02751476
Recruitment Status : Unknown
Verified January 2017 by Action Contre la Faim.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2016
Last Update Posted : January 31, 2017
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Action Contre la Faim

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.

Condition or disease Intervention/treatment Phase
Marasmus Other: Point of Use (PoU) water treatment flocculent disinfectant. Other: Point of Use (PoU) water treatment chlorine disinfectant Device: Point of Use (PoU) ceramic water filter Other: Standard Severe Acute Malnutrition Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 820 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition
Actual Study Start Date : April 2016
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: standard SAM treatment (control group)
Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure.
Other: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.

Experimental: SAM treatment + flocculent-disinfectant
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.
Other: Point of Use (PoU) water treatment flocculent disinfectant.
A household level point of use water treatment of a flocculent disinfectant will be tested.

Other: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.

Experimental: SAM treatment + chlorine disinfectant
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.
Other: Point of Use (PoU) water treatment chlorine disinfectant
A household level point of use water treatment of a chlorine disinfectant will be tested.

Other: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.

Experimental: SAM treatment + ceramic water filter
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.
Device: Point of Use (PoU) ceramic water filter
A household level point of use water treatment of a ceramic water filter will be tested.

Other: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751476


Sponsors and Collaborators
Action Contre la Faim
Johns Hopkins University
Investigators
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Principal Investigator: Shannon Doocy, PhD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Action Contre la Faim
ClinicalTrials.gov Identifier: NCT02751476     History of Changes
Other Study ID Numbers: PKG1A
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Malnutrition
Severe Acute Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Disinfectants
Anti-Infective Agents