Design and Clinical Evaluation of a School Meal With Deworming Properties
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|ClinicalTrials.gov Identifier: NCT02725255|
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : September 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Helminthiasis Tinea Capitis Anemia||Dietary Supplement: Ujiplus Drug: Albendazole Dietary Supplement: uji||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Design and Clinical Evaluation of a School Meal With Deworming Properties|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||March 2016|
Experimental: Papaya seed porridge
Arm receiving porridge fortified with dried papaya seeds (Ujiplus)
Dietary Supplement: Ujiplus
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.
Active Comparator: Albendazole and Plain porridge
Arm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds)
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.
Other Name: Albenza
Placebo Comparator: Plain porridge
arm receiving 300ml plain porridge daily (without papaya seeds)
Dietary Supplement: uji
maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.
- parasite egg count [ Time Frame: 60 days after randomization ]ova and cyst counts of various helminths in stool sample at end of intervention
- Body Mass Index for age [ Time Frame: 60 days after intervention ]Height, Weight and age were collected. BMI was calculated using WHO guidelines.
- school attendance [ Time Frame: 60 days after randomization ]school register used to gather information of attendance, enrollment and retention of students
- haemoglobin levels [ Time Frame: baseline and after 60 days ]blood sample is taken for hemoglobin amounts at start and end of intervention
- Number of children with tinea capitis [ Time Frame: 60 days after randomization ]Number of children with tinea capitis (ringworms) 60 days after randomization
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725255
|Principal Investigator:||Elijah M Songok, PhD||Kenya Medical Research Institute|