Design and Clinical Evaluation of a School Meal With Deworming Properties

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.

Conditions

• Helminthiasis
• Tinea Capitis
• Anemia

Interventions

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.

Sponsors & Collaborators

• United States Agency for International Development (USAID)

  collaborator FED

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Kenya Medical Research Institute

  lead OTHER

Principal Investigators

• Elijah M Songok, PhD · Kenya Medical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2015-11-30

Completion

2016-03-31