Anemia Clinical Trial
Official title:
Design and Clinical Evaluation of a School Meal With Deworming Properties
Intestinal parasites (IP) are among the world's neglected tropical diseases. Morbidity due to IPs is greatest in school-age children who typically have the highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale mass drug administration (MDA) of antihelminthic drugs to deworm children in developing countries. Though initially effective, there is concern that MDA might not be sustainable over extended periods especially considering the large children populations and the high frequency of dosing. Further, the MDAs exert increasing drug pressure on parasite populations, a circumstance that is likely to favor parasite genotypes that can resist anthelmintic drugs. There is hence a need for alternatives that are not only affordable and sustainable but easier to implement in the long term with a minimal chance of development of resistance. The investigators propose to develop and test the feasibility of a corn porridge meal fortified with papaya fruit extracts that have been shown to have antihelminthic properties. The investigators intend to evaluate its efficacy when given through school feeding programs and compare the outcome with albendazole- the recommended MDA agent for deworming school children. The investigators will design and formulate the product and test it among children in three primary schools in Western Kenya.
Background: Soil transmitted helminthes (STHs) are among the world's neglected tropical
diseases. Morbidity due to STHs is greatest in school-age children who typically have the
highest burden of infection. In 2001, WHO passed a resolution for the use of large-scale
mass drug administration (MDA) to deworm vulnerable children. Though effective, there is
concern that MDA might not be sustainable over extended periods. Additionally the current
MDA strategy do not consider child malnutrition, a very common malady in resource limited
countries. The investigators report a pilot evaluation of an innovation that bundles school
feeding and deworming.
The investigators designed a maize (corn) flour fortified with grounded dried papaya (Carica
papaya) seeds and used it to prepare porridge as per the usual school meal recipe. Children
from three primary schools from Nandi County in Kenya were randomized into three arms: One
school received 300 ml papaya fortified porridge daily (test school), a second school
received similar serving of plain porridge without the pawpaw ingredient (placebo) and a
third school received the placebo porridge and the conventional MDA approach of one time
400mg dosage of albendazole. Prior to the randomization, an initial baseline stool
microscopy analysis was done to determine presence and intensity of intestinal worms. Core
indicators of nutrition-height, weight and hemoglobin counts-were also assessed. The
children were monitored daily for two months and final stool sample analysis and clinical
monitoring done at the end of the study. Baseline and follow-up data were analyzed and
compared through SAS version 9.1 statistical package.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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