Clinical trial NCT03157336: Cassava Intervention Project
Official title: Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurotoxicity Syndrome, Cassava
Neurotoxicity Syndrome, Cyanate
Neurotoxicity Syndrome, Cyanide
Neurotoxicity Syndrome, Thiocyanate
Keywords: Cassava
Konzo
Cyanide
Cyanate
Thiocyanate
Carbamoylation
Isoprostanes
Oxidative Damage
Lead sponsor: Ministry of Public Health, Democratic Republic of the Congo
Sponsor class: OTHER_GOV
Collaborators: name: National Institutes of Health (NIH)
name: Oregon Health and Science University
name: Michigan State University
name: University of Kinshasa
name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2017-05-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in food cyanogenic exposure
timeFrame: From baseline to 6-month time points
measure: Change in internal cyanogenic exposure
timeFrame: From baseline to 6-month time points
measure: Change in oxidation damage
timeFrame: From baseline to 6-month time points
measure: Change in carbamoylation
timeFrame: From baseline to 6-month time points
measure: Change in carbamoylation surrogate
timeFrame: From baseline to 6-month time points
Secondary outcomes:
measure: Change in cognition performance
timeFrame: From baseline to 6-month time points
measure: Change in motor proficiency
timeFrame: From baseline to 6-month time points
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: INRB
Study officials:
affiliation: Ministry of Health
name: Mumba Ngoyi
role: STUDY_DIRECTOR
References: