An interventional study of Point of Use (PoU) water treatment flocculent disinfectant. and Point of Use (PoU) water treatment chlorine disinfectant in Marasmus, sponsored by Action Contre la Faim. Status unknown. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2017-01-31.
Sponsored by Action Contre la Faim · Not applicable, Interventional, and Treatment
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.
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.
40 studies on the registry are indexed under Protein-Energy Malnutrition; 7 are open to participants now.
This study's planned enrollment of 820 is above the median of 92 across 30 interventional studies indexed under Protein-Energy Malnutrition.
Browse Protein-Energy Malnutrition studies →Action Contre la Faim is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Children in each selected community will be eligible for inclusion in the study if they are
Exclusion Criteria:
Children will be ineligible for participation if
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 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. · Other: Standard Severe Acute Malnutrition Treatment
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 · Other: Standard Severe Acute Malnutrition Treatment
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 · Other: Standard Severe Acute Malnutrition Treatment
A household level point of use water treatment of a flocculent disinfectant will be tested.
A household level point of use water treatment of a chlorine disinfectant will be tested.
A household level point of use water treatment of a ceramic water filter will be tested.
Standard CMAM treatment.
Recovery rate
the total number of cured children / total number of exited children (including cured, deceased, and lost to follow-up)
Time frame: 5 months
No study locations are listed for this record.
Plan to share: Undecided
Ran from Apr 2016 to primary completion in Oct 2016, 6 months.
Of 16 interventional studies with no phase under Protein-Energy Malnutrition, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 41. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Action Contre la Faim