HelminthiasisPhase 2/3NCT02725255
Design and Clinical Evaluation of a School Meal With Deworming Properties
A Phase 2/3 study testing Ujiplus, Albendazole and uji in people with Helminthiasis and Tinea Capitis, run by Kenya Medical Research Institute.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Helminthiasis, Tinea Capitis, Anemia
- What is being tested?
- Ujiplus, Albendazole and uji
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Consenting parents and guardians
Who cannot join
- children with known allergy to papaya fruit products
About this study
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.
Read the 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.
- Conditions
- Helminthiasis, Tinea Capitis, Anemia
- Being tested
- Ujiplus, Albendazole, uji
- Medical subject headings
- Helminthiasis, Tinea Capitis, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UjiplusDietary 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.
AlbendazoleDrug
Also called Albenza
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.
ujiDietary supplement
maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Papaya seed porridge | Experimental | Arm receiving porridge fortified with dried papaya seeds (Ujiplus) Receives: 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) Receives: Drug: Albendazole |
| Plain porridge | Placebo comparator | arm receiving 300ml plain porridge daily (without papaya seeds) Receives: Dietary Supplement: uji |
What is being measured
The primary outcome is the main question the study is designed to answer.
parasite egg count
ova and cyst counts of various helminths in stool sample at end of intervention
Measured: 60 days after randomization
Secondary outcomes (4)
Body Mass Index for age
Height, Weight and age were collected. BMI was calculated using WHO guidelines.
Measured: 60 days after intervention
school attendance
school register used to gather information of attendance, enrollment and retention of students
Measured: 60 days after randomization
haemoglobin levels
blood sample is taken for hemoglobin amounts at start and end of intervention
Measured: baseline and after 60 days
Number of children with tinea capitis
Number of children with tinea capitis (ringworms) 60 days after randomization
Measured: 60 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HelminthiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenya Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Elijah M. Songok, Kenya Medical Research Institute
- Investigators
- Elijah M Songok, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725255
- Sponsor's protocol ID
- SSC2580
- Status last verified
- Sep 2016
- First submitted
- 28 Feb 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 17472487Kermanshai 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.
PubMed 11393524Ash LR, Orihel TC, Savioli L. Bench aids for the diagnosis of intestinal parasites. Geneva. World Health Organization, 1994
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.
PubMed 23202594Kugo 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.
PubMed 30526582
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Clinical Evaluation of a School Meal With Deworming Properties
- ClinicalTrials.gov ID
- NCT02725255
- Acronym / sponsor ID
- SSC2580
- Conditions
- Helminthiasis, Tinea Capitis, Anemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Kenya Medical Research InstituteUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Bill and Melinda Gates Foundation
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Papaya seed porridge | Experimental | Dietary Supplement: UjiplusArm receiving porridge fortified with dried papaya seeds (Ujiplus) |
| Albendazole and Plain porridge | Active comparator | Drug: AlbendazoleArm receiving the approved albendazole treatment of 400mg once with plain porridge daily (without papaya seeds) |
| Plain porridge | Placebo comparator | Dietary Supplement: ujiarm receiving 300ml plain porridge daily (without papaya seeds) |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Consenting parents and guardians
Key exclusion criteria (1 listed)
- children with known allergy to papaya fruit products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UjiplusMaize 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. | Dietary supplement | Papaya seed porridge |
| AlbendazoleAlso: Albenza400mg 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. | Drug | Albendazole and Plain porridge |
| ujimaize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days. | Dietary supplement | Plain porridge |
Primary outcome
parasite egg count
Time frame: 60 days after randomization
ova and cyst counts of various helminths in stool sample at end of intervention
4 secondary outcomes
Body Mass Index for age
Time frame: 60 days after intervention
school attendance
Time frame: 60 days after randomization
haemoglobin levels
Time frame: baseline and after 60 days
Number of children with tinea capitis
Time frame: 60 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Background: PubMed 17472487Okeniyi 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.
- Background: PubMed 11393524Kermanshai 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.
- BackgroundAsh LR, Orihel TC, Savioli L. Bench aids for the diagnosis of intestinal parasites. Geneva. World Health Organization, 1994
- Background: PubMed 23202594Sapaat 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.
- Derived from this study: PubMed 30526582Kugo 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elijah M Songok, PhD principal investigator
Kenya Medical Research Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ujiplus, Albendazole and uji in people with Helminthiasis and Tinea Capitis, run by Kenya Medical Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parasite egg count (time frame: 60 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725255, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.