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

January 27, 2017 updated by: Action Contre la Faim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
820

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.
Other: Point of Use (PoU) water treatment flocculent disinfectant.
A household level point of use water treatment of a flocculent disinfectant will be tested.
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: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.
Other: Point of Use (PoU) water treatment chlorine disinfectant
A household level point of use water treatment of a chlorine disinfectant will be tested.
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.
Other: Standard Severe Acute Malnutrition Treatment
Standard CMAM treatment.
Device: Point of Use (PoU) ceramic water filter
A household level point of use water treatment of a ceramic water filter will be tested.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Action Contre la Faim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shannon Doocy, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PKG1A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings