Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201209000406105 Date of Approval: 30/08/2012
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact and acceptability of using Moringa oleifera seeds and handwashing with soap to improve household drinking water and diarrhoea incidence
Official scientific title Impact and acceptability of using Moringa oleifera seeds and handwashing with soap to improve household drinking water and diarrhoea incidence in Poor Rural Tanzania
Brief summary describing the background and objectives of the trial The research aims to provide alternative disease prevention interventions that are cheap, effective, environmentally sound and locally sustainable, using appropriate technology acceptable to the local population. The research is looking at the impact of using a traditional flocculent (Moringa oleifera seeds) and handwashing with soap at household level to improve drinking water quality and in reducing the incidence of diarrhoea disease in Kumnazi and Nyakariba villages, Ngara district in Kagera.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diarrhoea, pneumonia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 31/07/2012
Actual trial start date 31/07/2012
Anticipated date of last follow up 30/08/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
NIMR/HQ/R.8a/Vol. IX/1464 National Institute for Medical Research
LSHTM 6113/28052012 London School of Hygiene and Tropical Medicine Ethics Committee
IHI/IRB/No. 16-2012 Ifakara Health Institute-Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a pre-identified list of clusters Sealed opague envelopes, closed containers,and community members who were not aware of the exercise Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Moringa Arm 2 seeds per 5 litres of untreated drinking water, everyday 13 months Crushed Moringa oleifera seeds act as a flocculant by promoting a rapid settlement of suspended particles and pathogens when applied to water. The seeds contain large positively charged protein molecules that attract smaller negatively charged proteins such as those found in silt, clay and bacteria achieving turbidity reduction of 80-99.5% and significant primary bacterial reduction of 90-99.99%. 102
Experimental Group Handwashing Arm Handwashing with soap at key times, everyday 13 months Promotion of handwashing with soap, Hygiene promotion and education is provided. They also receive translated instruction sheet that illustrates procedures for proper handwashing with soap. A handwashing station (tippy tap) and a special soap for hand washing in order to prevent in-house drinking water contamination. Soaps are distributed on weekly basis. 102
Control Group Control Arm NA 13 months NA 102
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Located within the study area Consent to participate Loss to follow up Drop out voluntarily 1 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/03/2012 Ifakara Health Institute Review Board (IHI-IRB)
Ethics Committee Address
Street address City Postal code Country
Kiko Avenue, Mikocheni Dar Es Salaam +255 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/05/2012 London School of Hygiene and Tropical Medicine Ethics Committee (LSHTM-EC)
Ethics Committee Address
Street address City Postal code Country
Keppel Street London WC 1E 7HT United Kingdom
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/01/2013 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
2448, Ocean Road, P.O.BOX 9653 Dar es Salaam +255 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/01/2013 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
2448, Ocean Road, P.O.BOX 9653 Dar es Salaam +255 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/01/2013 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
2448, Ocean Road, P.O.BOX 9653 Dar es Salaam +255 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Water quality (Escherichia coli concentrations) Water samples are collected from source and from containers used by the family to store drinking water. All households in each arm and their corresponding sources will be sampled at least once a month (to minimize the effect of seasonality and inter-household variations). Households to be visited each month are randomly selected using the random number generator in excel.
Secondary Outcome Diarrhoea, dysentry, pneumonia, fever Households are visited on weekly basis. Care givers or female heads of households will be asked for number of days with diarrhoea or dysentery, or pneumonia among children under the age of 5. Data will be recorded with a maximum recall period of seven days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Concern Worldwide - Ngara field office Mwinyi Road Ngara +255 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Concern Worldwide Plot 169, Regent Estate Dar Es Salaam +255 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Ifakara Health Institute Kiko Avenue, Mikocheni Dar Es Salaam +255 Tanzania Charities/Societies/Foundation
Primary Sponsor Concern Worldwide Plot 169, Regent Estate Dar Es Salaam +255 Tanzania Funding Agency
Secondary Sponsor London School of Hygiene and Tropical Medicine Keppel Street London WC 1E 7HT United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
London School of Hygiene and Tropical Medicine Keppel Street London WC 1E 7HT United Kingdom
Ifakara Health Institute Kiko Avenue, Mikocheni Dar Es Salaam +255 Tanzania
Concern Worldwide Plot 169, Regent Estate Dar Es Salaam +255 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Frank Mng'ong'o frank.mngongo@concern.net +255 0 28 2226220 Mwinyi Road
City Postal code Country Position/Affiliation
Ngara +255 Tanzania Research officer at Concern Worldwide, PhD student at London School of Hygiene and Tropical Medicine
Role Name Email Phone Street address
Public Enquiries Sarah Moore smoore@ihi.or.tz +255 7892 34298 Kiko Ave, Mikocheni
City Postal code Country Position/Affiliation
Dar Es Salaam Tanzania Research fellow at Ifakara Health Institutie and Lecturer at LSHTM
Role Name Email Phone Street address
Scientific Enquiries Jeroen Ensink jeroen.ensink@lshtm.ac.uk +44 20 7927 2124 Keppel Street
City Postal code Country Position/Affiliation
London WC1E 7HT United Kingdom Lecturer LSHTM and PhD Supervisor for Frank Mng'ong'o
REPORTING
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