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

Marasmus Clinical Trial

Official title:

Effectiveness of Safe Drinking Water in Community Based Treatment of Severe Acute Malnutrition

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02751476
• Other study ID #: PKG1A
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2016
• Last updated: January 27, 2017
• Start date: April 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Action Contre la Faim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 820
• Est. completion date: March 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Marasmus
• Protein-Energy Malnutrition
• Severe Acute Malnutrition

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Action Contre la Faim	Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery rate	the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)	5 months