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.: PACTR201901631942297 Date of Approval: 24/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Training caregivers to enhance early child neurodevelopment in the prevention of konzo disease from toxic cassava in the Democratic Republic of Congo
Official scientific title Training caregivers to enhance early child neurodevelopment in the prevention of konzo disease from toxic cassava in the Democratic Republic of Congo
Brief summary describing the background and objectives of the trial Konzo is an irreversible neurological disease of sudden onset with permanent partial paralysis in the legs. It is caused by chronic consumption of poorly processed cassava that has high levels of cyanide, and affects mostly women and children. We are the first group to document neurocognitive affects in konzo, and disease risk in very young children. Brain development is affected much more and at an earlier stage than previously known. The DR Congo government, with the support of WHO, is beginning to train mothers in konzo outbreak regions to use a cassava processing wetting method (WTM) that can make remove the cyanide from the cassava flour before eaten. We will embed WTM training within Early Childhood Development (ECD) caregiver training that will better motivate the use of the WTM to save the family from konzo. This ECD program also gives moms practical strategies for stimulating cognitive/physical development while using WTM to save children's brains from cyanide in the food. The principal objective of the present partnership proposal is to adapt the caregiver training and child neurodevelopmental assessment capacity to a community-based intervention model for the prevention of konzo in the DR Congo
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/06/2018
Actual trial start date 01/03/2019
Anticipated date of last follow up 30/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Wetting method and Mediational Intervention for Sensitizing Children 24 months intervention study The present proposal is to embed training for Wetting method (WTM) that is a cassava detoxification method, within a curriculum of mediational intervention for sensitizing caregivers (MISC) that can not only lead to safer food preparation practices to prevent konzo, but provide mothers with practical strategies for enhancing the cognitive and social development of their children by enriching their daily interactions in the household. 200 Active-Treatment of Control Group
Experimental Group Wetting method 24 months intervention study We recently implemented an efficient cassava processing method in the Congo (DRC), the “wetting method (WTM)” that was taught to rural women to efficiently minimize the amount of cyanogens in cassava prior to human consumption which, helped prevent outbreaks of konzo. In collaboration with the Ministry of Health branch to promote good nutrition in the DRC, we are presently launching a cluster randomized controlled trial enlisting household food providers (mothers) who have been successfully trained in the WTM, as peer trainers, training small groups of other mothers throughout a two-year period intervention for the safer processing of cassava for their families. 200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All mother-child dyads with children aged 0-5 years Dyads living in Kahemba (study site) Informed consent to participate in the study Children with infectious or somatic conditions that can affect early child cognitive development Children with other neurological conditions that can affect early child cognitive development Infant: 0 Month-23 Month,Preschool Child: 2 Year-5 Year 0 Month(s) 60 Month(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 12/11/2018 Ministry of Health National Ethic Comittee
Ethics Committee Address
Street address City Postal code Country
PNMLS 1e niveau local 5 Kinshasa 1391 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be changes in cassava cyanogenic content by the trainees and Urine thiocyanate level in the children in their MISC/WTM versus WTM only intervention households and enhance early child development and neurocognition of children in the 200 included households. 6 months follow-up, 12 months, 18 month and 24 month follow-up
Secondary Outcome Neurodevelopmental and cognitive performance scores in the children using selected tools for neurocognitive assessments 6 months follow-up, 12 months, 18 months and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institut National de Recherche Biomdicale 5345 Avenue de la Democratie Huileries Kinshasa Democratic Republic of the Congo
Kahemba Health Zone Avenue Kahemba Kahemba Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Canada Saving Brains MaRS Center West Tower 665 university avenue suite 1720 Toronto Canada
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Kinshasa Avenue universite Kinshasa Democratic Republic of the Congo University
Secondary Sponsor Institut National de Recherche Biomedicale avenue de la democratie ex huileries Kinshasa Democratic Republic of the Congo National Research Institution
COLLABORATORS
Name Street address City Postal code Country
Michael Boivin Michigan State University Michigan United States of America
Desire Tshala Katumbay Oregon Health Science University Oregon United States of America
Daniel Okitundu University of Kinshasa Kinshasa Democratic Republic of the Congo
Dieudonne Mumba INRB Kinshasa Democratic Republic of the Congo
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Esperance Kashala Abotnes esperance_kashala@yahoo.com +4741003043 Lysskar 30 B
City Postal code Country Position/Affiliation
Haugesund Norway INRB
Role Name Email Phone Street address
Public Enquiries Esperance Kashala Abotnes esperance_kashala@yahoo.com +41003043 Lysskar 30 B
City Postal code Country Position/Affiliation
Haugesund Norway INRB
Role Name Email Phone Street address
Scientific Enquiries Michael Boivin michael.boivin@hc.msu.edu +17655062163 Michigan States University East Lansing
City Postal code Country Position/Affiliation
East Lansing United States of America Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information