Cassava Intervention Project
Primary Purpose
Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide
Status
Completed
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Non Inferiority WTM Interventional Trial
Sponsored by
About this trial
This is an interventional prevention trial for Neurotoxicity Syndrome, Cassava focused on measuring Cassava, Konzo, Cyanide, Cyanate, Thiocyanate, Carbamoylation, Isoprostanes, Oxidative Damage
Eligibility Criteria
Inclusion Criteria:
- Households with a konzo child and non-konzo sibling between 5 and 12 years
- Presence of a biological mother primarily responsible for the household food preparation and caring for the children
- Mother consenting to participate in this study
Exclusion Criteria:
- History of seizures
- History of cerebral malaria
- History of retroviral (HIV-HTLV) infections
Sites / Locations
- INRB
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Peer-led Intervention
Specialist-led Intervention
Arm Description
Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.
Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..
Outcomes
Primary Outcome Measures
Change in food cyanogenic exposure
Cassava cyanogenic content
Change in internal cyanogenic exposure
Urinary concentrations of thiocyanate (U-SCN)
Change in oxidation damage
Serum isoprostanes
Change in carbamoylation
serum albumin peptidic carbamoylation
Change in carbamoylation surrogate
serum homocitrulline
Secondary Outcome Measures
Change in cognition performance
Kaufman Assessment Battery for Children (KABC-II) for cognition testing score
Change in motor proficiency
Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score
Full Information
NCT ID
NCT03157336
First Posted
May 12, 2017
Last Updated
June 3, 2022
Sponsor
Ministry of Public Health, Democratic Republic of the Congo
Collaborators
National Institutes of Health (NIH), Oregon Health and Science University, Michigan State University, University of Kinshasa, National Institute of Environmental Health Sciences (NIEHS)
1. Study Identification
Unique Protocol Identification Number
NCT03157336
Brief Title
Cassava Intervention Project
Official Title
Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2017 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Public Health, Democratic Republic of the Congo
Collaborators
National Institutes of Health (NIH), Oregon Health and Science University, Michigan State University, University of Kinshasa, National Institute of Environmental Health Sciences (NIEHS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigators will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists.
Detailed Description
The proposed project seeks methods to prevent and elucidate biomarkers of neurocognition and motor deficits associated with chronic dietary reliance on cyanogenic cassava, a staple food crop for more than 600 millions of people living in the tropics. Aim 1 will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (women training other women in the WTM) with that by community-health worker specialists (2 intervention training arms). Aim 2 will determine whether post-intervention reductions in cassava cyanogenic content and child U-SCN are associated with changes in biomarkers of cassava neurotoxicity particularly 8,12-iso-iPF2α-VI isoprostane (oxidant marker), carbamoylated albumin fragments KVPQVSTPTLVEVSR (residues 438-452) and LDELRDEGKASSAK (residues 206-219), or homocitrulline (carbamoylating markers), and scores at the KABC-II cognition and BOT-2 motor testing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide, Neurotoxicity Syndrome, Thiocyanate
Keywords
Cassava, Konzo, Cyanide, Cyanate, Thiocyanate, Carbamoylation, Isoprostanes, Oxidative Damage
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will implement a novel cassava processing method (wetting method, WTM) that safely removes cyanogenic compounds from cassava flour prior to human consumption in a stratified village-cluster randomized non-inferiority trial so as to compare the effectiveness of a peer-led intervention (Arm 1 = women training other women in the WTM) with that by community-health worker specialists (Arm 2= specialist led intervention arm)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peer-led Intervention
Arm Type
Experimental
Arm Description
Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.
Arm Title
Specialist-led Intervention
Arm Type
Experimental
Arm Description
Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..
Intervention Type
Other
Intervention Name(s)
Non Inferiority WTM Interventional Trial
Intervention Description
The intervention will implement the WTM cassava processing technique in participating households. Twenty women (in leading roles) will be our principal candidates to serve as peer trainers. Together with a 20 community health worker specialists, these women will be trained in the WTM technique by the Kinshasa team of community health workers who are experts in the WTM method. Those who master the technique will then be certified as trainers to train and support other small groups of other mothers throughout a two-year period in the implementation of the WTM for the safer processing of food for their families. Both the community health worker specialists and trained women (prospective trainers) would have to be able to bring the cassava cyanogenic content to the lowest achievable level, which must be < 10 ppm as per the recommendations of the World Health Organization.
Primary Outcome Measure Information:
Title
Change in food cyanogenic exposure
Description
Cassava cyanogenic content
Time Frame
From baseline to 6-month time points
Title
Change in internal cyanogenic exposure
Description
Urinary concentrations of thiocyanate (U-SCN)
Time Frame
From baseline to 6-month time points
Title
Change in oxidation damage
Description
Serum isoprostanes
Time Frame
From baseline to 6-month time points
Title
Change in carbamoylation
Description
serum albumin peptidic carbamoylation
Time Frame
From baseline to 6-month time points
Title
Change in carbamoylation surrogate
Description
serum homocitrulline
Time Frame
From baseline to 6-month time points
Secondary Outcome Measure Information:
Title
Change in cognition performance
Description
Kaufman Assessment Battery for Children (KABC-II) for cognition testing score
Time Frame
From baseline to 6-month time points
Title
Change in motor proficiency
Description
Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score
Time Frame
From baseline to 6-month time points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Households with a konzo child and non-konzo sibling between 5 and 12 years
Presence of a biological mother primarily responsible for the household food preparation and caring for the children
Mother consenting to participate in this study
Exclusion Criteria:
History of seizures
History of cerebral malaria
History of retroviral (HIV-HTLV) infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mumba Ngoyi
Organizational Affiliation
Ministry of Health
Official's Role
Study Director
Facility Information:
Facility Name
INRB
City
Kinshasa
Country
Congo, The Democratic Republic of the
12. IPD Sharing Statement
Plan to Share IPD
No
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Cassava Intervention Project
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