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Design and Clinical Evaluation of a School Meal With Deworming Properties

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ClinicalTrials.gov Identifier: NCT02725255
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Elijah M. Songok, Kenya Medical Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Helminthiasis Tinea Capitis Anemia Dietary Supplement: Ujiplus Drug: Albendazole Dietary Supplement: uji Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Design and Clinical Evaluation of a School Meal With Deworming Properties
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Albendazole

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 Name: 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.




Primary Outcome Measures :
  1. parasite egg count [ Time Frame: 60 days after randomization ]
    ova and cyst counts of various helminths in stool sample at end of intervention


Secondary Outcome Measures :
  1. Body Mass Index for age [ Time Frame: 60 days after intervention ]
    Height, Weight and age were collected. BMI was calculated using WHO guidelines.

  2. school attendance [ Time Frame: 60 days after randomization ]
    school register used to gather information of attendance, enrollment and retention of students

  3. haemoglobin levels [ Time Frame: baseline and after 60 days ]
    blood sample is taken for hemoglobin amounts at start and end of intervention

  4. Number of children with tinea capitis [ Time Frame: 60 days after randomization ]
    Number of children with tinea capitis (ringworms) 60 days after randomization



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consenting parents and guardians

Exclusion Criteria:

  • children with known allergy to papaya fruit products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725255


Sponsors and Collaborators
Kenya Medical Research Institute
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Elijah M Songok, PhD Kenya Medical Research Institute
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elijah M. Songok, Prof. Elijah M. Songok, Kenya Medical Research Institute
ClinicalTrials.gov Identifier: NCT02725255    
Other Study ID Numbers: SSC2580
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Tinea Capitis
Helminthiasis
Parasitic Diseases
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Scalp Dermatoses
Skin Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents