Design and Clinical Evaluation of a School Meal With Deworming Properties

NCT02725255 | Completed Phase 2

• 1 other identifier: SSC2580
• Study Type: interventional
• Target: 326
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helminthiasis; Tinea Capitis; Anemia

Outcome Measures

Primary Outcomes (1)

• parasite egg count

  ova and cyst counts of various helminths in stool sample at end of intervention

  60 days after randomization

Secondary Outcomes (4)

• Body Mass Index for age

  60 days after intervention

• school attendance

  60 days after randomization

• haemoglobin levels

  baseline and after 60 days

• Number of children with tinea capitis

  60 days after randomization

Study Arms (3)

Papaya seed porridge

EXPERIMENTAL

Arm receiving porridge fortified with dried papaya seeds (Ujiplus)

Dietary Supplement: Ujiplus

Albendazole and Plain porridge

ACTIVE COMPARATOR

Arm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds)

Drug: Albendazole

Plain porridge

PLACEBO COMPARATOR

arm receiving 300ml plain porridge daily (without papaya seeds)

Dietary Supplement: uji

Interventions

Ujiplus DIETARY_SUPPLEMENT

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.

Papaya seed porridge

Albendazole DRUG

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.

Also known as: Albenza

Albendazole and Plain porridge

uji DIETARY_SUPPLEMENT

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

Plain porridge

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Consenting parents and guardians

You may not qualify if:

• children with known allergy to papaya fruit products

Sponsors & Collaborators

• Kenya Medical Research Institute: lead
• United States Agency for International Development (USAID): collaborator
• Bill and Melinda Gates Foundation: collaborator

Related Publications (5)

• 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. doi: 10.1089/jmf.2005.065.

  PMID: 17472487 BACKGROUND

• 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. doi: 10.1016/s0031-9422(01)00077-2.

  PMID: 11393524 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 23202594 BACKGROUND

• Kugo M, Keter L, Maiyo A, Kinyua J, Ndemwa P, Maina G, Otieno P, Songok EM. Fortification of Carica papaya fruit seeds to school meal snacks may aid Africa mass deworming programs: a preliminary survey. BMC Complement Altern Med. 2018 Dec 7;18(1):327. doi: 10.1186/s12906-018-2379-2.

  PMID: 30526582 DERIVED

MeSH Terms

Conditions

Helminthiasis; Tinea Capitis; Anemia

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic Diseases; Infections; Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Scalp Dermatoses; Skin Diseases; Skin and Connective Tissue Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elijah M Songok, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Elijah M. Songok

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 31, 2016
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share