Design and Clinical Evaluation of a School Meal With Deworming Properties

Anemia Clinical Trial

Official title:

Design and Clinical Evaluation of a School Meal With Deworming Properties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725255
• Other study ID #: SSC2580
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 28, 2016
• Last updated: September 3, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Kenya Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• Consenting parents and guardians

Exclusion Criteria:

• children with known allergy to papaya fruit products

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Helminthiasis
• Tinea Capitis

Intervention

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.

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.

Dietary Supplement:
• uji
maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kenya Medical Research Institute	Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

References & Publications (4)

Ash LR, Orihel TC, Savioli L. Bench aids for the diagnosis of intestinal parasites. Geneva. World Health Organization, 1994

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parasite egg count	ova and cyst counts of various helminths in stool sample at end of intervention	60 days after randomization	No
Secondary	Body Mass Index for age	Height, Weight and age were collected. BMI was calculated using WHO guidelines.	60 days after intervention	No
Secondary	school attendance	school register used to gather information of attendance, enrollment and retention of students	60 days after randomization	No
Secondary	haemoglobin levels	blood sample is taken for hemoglobin amounts at start and end of intervention	baseline and after 60 days	Yes
Secondary	Number of children with tinea capitis	Number of children with tinea capitis (ringworms) 60 days after randomization	60 days after randomization	No