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.

Study Overview

• Status: Completed
• Conditions: Anemia; Helminthiasis; Tinea Capitis
• Intervention / Treatment: Dietary supplement: Ujiplus; Drug: Albendazole; Dietary supplement: uji

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.

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consenting parents and guardians

Exclusion Criteria:

• children with known allergy to papaya fruit products

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Drug: Albendazole; 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 Names: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kenya Medical Research Institute
• Collaborators: United States Agency for International Development (USAID); Bill and Melinda Gates Foundation

Publications and helpful links

General Publications

• Okeniyi JA, Ogunlesi TA, Oyelami OA, Adeyemi LA. Effectiveness of dried Carica papaya seeds against human intestinal parasitosis: a pilot study. J Med Food. 2007 Mar;10(1):194-6. doi: 10.1089/jmf.2005.065.
• Kermanshai R, McCarry BE, Rosenfeld J, Summers PS, Weretilnyk EA, Sorger GJ. Benzyl isothiocyanate is the chief or sole anthelmintic in papaya seed extracts. Phytochemistry. 2001 Jun;57(3):427-35. doi: 10.1016/s0031-9422(01)00077-2.
• Ash LR, Orihel TC, Savioli L. Bench aids for the diagnosis of intestinal parasites. Geneva. World Health Organization, 1994
• Sapaat A, Satrija F, Mahsol HH, Ahmad AH. Anthelmintic activity of papaya seeds on Hymenolepis diminuta infections in rats. Trop Biomed. 2012 Dec;29(4):508-12.
• Kugo M, Keter L, Maiyo A, Kinyua J, Ndemwa P, Maina G, Otieno P, Songok EM. Fortification of Carica papaya fruit seeds to school meal snacks may aid Africa mass deworming programs: a preliminary survey. BMC Complement Altern Med. 2018 Dec 7;18(1):327. doi: 10.1186/s12906-018-2379-2.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 28, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): March 31, 2016

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 3, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Parasitic Diseases; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Scalp Dermatoses; Helminthiasis; Tinea Capitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: SSC2580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes