Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide, Neurotoxicity Syndrome, Thiocyanate
Conditions
Keywords
Cassava, Konzo, Cyanide, Cyanate, Thiocyanate, Carbamoylation, Isoprostanes, Oxidative Damage
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.
Interventions
OTHERNon Inferiority WTM Interventional Trial
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.
Sponsors
National Institutes of Health (NIH)
Oregon Health and Science University
Michigan State University
University of Kinshasa
National Institute of Environmental Health Sciences (NIEHS)
Ministry of Public Health, Democratic Republic of the Congo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in internal cyanogenic exposure | From baseline to 6-month time points | Urinary concentrations of thiocyanate (U-SCN) |
| Change in carbamoylation | From baseline to 6-month time points | serum albumin peptidic carbamoylation |
| Change in carbamoylation surrogate | From baseline to 6-month time points | serum homocitrulline |
| Change in food cyanogenic exposure | From baseline to 6-month time points | Cassava cyanogenic content |
| Change in oxidation damage | From baseline to 6-month time points | Serum isoprostanes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in motor proficiency | From baseline to 6-month time points | Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score |
| Change in cognition performance | From baseline to 6-month time points | Kaufman Assessment Battery for Children (KABC-II) for cognition testing score |
Countries
Democratic Republic of the Congo
Outcome results
None listed