Severe and Moderate Malnutrition Clinical Trial
Official title:
Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns
Malnutrition is the leading cause of death in children in developing countries, especially
Pakistan. According to World Health Organization about 60% of all deaths, occurring among
children aged less than five years in developing countries, could be attributed to
malnutrition.
Community-based therapeutic care attempts to maximize population-level impact through
improved coverage, access, and cost-effectiveness of treatment. Such community-based
nutrition packages can provide effective care to the majority of acutely malnourished
children as outpatients, using techniques of community mobilization to engage the affected
population and maximize coverage and compliance. Children with SAM without medical
complications are treated in an outpatient therapeutic program with ready-to-use therapeutic
food and routine medications.
The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized
the treatment of moderate and severe malnutrition. The advantage of these commodities is
that they are ready-to-use paste which does not need to be mixed with water, thereby
avoiding the risk of bacterial proliferation in case of accidental contamination.
Aim:
To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement
(Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when
administered at community level
Primary objectives:
- To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified
supplementary food (RUTF) in the treatment of moderate malnutrition in children less
than three years of age in community settings.
- To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of
severe malnutrition in children less than three years of age in community settings.
Methodology:
Study Design: Community based, step wedge randomized trial
Sample size estimation:
Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040
(Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520
(Assuming 50% of Under 5 Population)
Sample Size for Moderate Malnutrition:
It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520:
904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or
drop outs)
Sample Size For Severe Malnutrition:
It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of
4520: 360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups
or drop outs)
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment