Anemia Clinical Trial
Official title:
Design and Clinical Evaluation of a School Meal With Deworming Properties
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kenya Medical Research Institute | Bill and Melinda Gates Foundation, United States Agency for International Development (USAID) |
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
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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