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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02725255
Other study ID # SSC2580
Secondary ID
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


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
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