Design and Clinical Evaluation of a School Meal With Deworming Properties
Condition: Helminthiasis; Tinea Capitis; Anemia
MeSH terms: Helminthiasis; Tinea Capitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Ujiplus; Albendazole; uji
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): Maize flour fortified with micronutrients and dried ground papaya (Carica papaya) seeds. The flour was used to prepare porridge and each child given a serving of 300 ml every school day for 60 days.; 400mg of albendazole given to each child once at the beginning of the study and maize flour porridge fortified only with micronutrients cooked and served to each child, 300ml per day for 60 days.; maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.
Other intervention name(s): Albenza
Intervention MeSH terms: Albendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment