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

Primary Purpose

Marasmus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
Sponsored by
Action Contre la Faim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marasmus

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    standard SAM treatment (control group)

    SAM treatment + flocculent-disinfectant

    SAM treatment + chlorine disinfectant

    SAM treatment + ceramic water filter

    Arm Description

    Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Recovery rate
    the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)

    Secondary Outcome Measures

    Full Information

    First Posted
    April 22, 2016
    Last Updated
    January 27, 2017
    Sponsor
    Action Contre la Faim
    Collaborators
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02751476
    Brief Title
    Effectiveness of Safe Drinking Water in Treatment of Severe Acute Malnutrition (Pakistan)
    Official Title
    Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    March 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Action Contre la Faim
    Collaborators
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Marasmus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    820 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    standard SAM treatment (control group)
    Arm Type
    Active Comparator
    Arm Description
    Standard Severe acute malnutrition treatment provided according to national nutrition protocol, in link with MoH health centers and structure.
    Arm Title
    SAM treatment + flocculent-disinfectant
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    SAM treatment + chlorine disinfectant
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    SAM treatment + ceramic water filter
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Point of Use (PoU) water treatment flocculent disinfectant.
    Intervention Description
    A household level point of use water treatment of a flocculent disinfectant will be tested.
    Intervention Type
    Other
    Intervention Name(s)
    Point of Use (PoU) water treatment chlorine disinfectant
    Intervention Description
    A household level point of use water treatment of a chlorine disinfectant will be tested.
    Intervention Type
    Device
    Intervention Name(s)
    Point of Use (PoU) ceramic water filter
    Intervention Description
    A household level point of use water treatment of a ceramic water filter will be tested.
    Intervention Type
    Other
    Intervention Name(s)
    Standard Severe Acute Malnutrition Treatment
    Intervention Description
    Standard CMAM treatment.
    Primary Outcome Measure Information:
    Title
    Recovery rate
    Description
    the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)
    Time Frame
    5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    59 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shannon Doocy, PhD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30132426
    Citation
    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.
    Results Reference
    derived

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

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