Design and Clinical Evaluation of a School Meal With Deworming Properties

Study Overview
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Brief Summary
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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
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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.

Official Title
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Design and Clinical Evaluation of a School Meal With Deworming Properties

Conditions
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Helminthiasis, Tinea Capitis, Anemia

Intervention / Treatment
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* Dietary Supplement: Ujiplus
* Drug: Albendazole
* Dietary Supplement: uji


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting parents and guardians Exclusion Criteria: children with known allergy to papaya fruit products

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Papaya seed porridge<br>Arm receiving porridge fortified with dried papaya seeds (Ujiplus) | Dietary Supplement: Ujiplus<br>* 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.<br>|
| Active Comparator: Albendazole and Plain porridge<br>Arm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds) | Drug: Albendazole<br>* 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.<br>* Other names: Albenza;|
| Placebo Comparator: Plain porridge<br>arm receiving 300ml plain porridge daily (without papaya seeds) | Dietary Supplement: uji<br>* maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parasite egg count | ova and cyst counts of various helminths in stool sample at end of intervention | 60 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index for age | Height, Weight and age were collected. BMI was calculated using WHO guidelines. | 60 days after intervention | 
| school attendance | school register used to gather information of attendance, enrollment and retention of students | 60 days after randomization | 
| haemoglobin levels | blood sample is taken for hemoglobin amounts at start and end of intervention | baseline and after 60 days | 
| Number of children with tinea capitis | Number of children with tinea capitis (ringworms) 60 days after randomization | 60 days after randomization |