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

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: Unknown
• Conditions: Marasmus
• Intervention / Treatment: Other: Standard Severe Acute Malnutrition Treatment; 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

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: Interventional
• Enrollment (Anticipated): 820
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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: 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

Outcome Measure	Measure Description	Time Frame
Recovery rate	the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)	5 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: April 22, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Protein Deficiency; Malnutrition; Severe Acute Malnutrition; Protein-Energy Malnutrition; Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: PKG1A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided