Cassava Intervention Project

Neurotoxicity Syndrome, Cassava Clinical Trial

Official title:

Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157336
• Other study ID #: FWA00017202
• Secondary ID: R01ES019841
• Status: Completed
• Phase: N/A
• Start date: July 30, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Ministry of Public Health, Democratic Republic of the Congo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurotoxicity Syndrome, Cassava
• Neurotoxicity Syndrome, Cyanate
• Neurotoxicity Syndrome, Cyanide
• Neurotoxicity Syndrome, Thiocyanate
• Neurotoxicity Syndromes
• Syndrome

Intervention

Other:
• Non 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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	INRB	Kinshasa

Sponsors (6)

Lead Sponsor	Collaborator
Ministry of Public Health, Democratic Republic of the Congo	Michigan State University, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Oregon Health and Science University, University of Kinshasa

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in food cyanogenic exposure	Cassava cyanogenic content	From baseline to 6-month time points
Primary	Change in internal cyanogenic exposure	Urinary concentrations of thiocyanate (U-SCN)	From baseline to 6-month time points
Primary	Change in oxidation damage	Serum isoprostanes	From baseline to 6-month time points
Primary	Change in carbamoylation	serum albumin peptidic carbamoylation	From baseline to 6-month time points
Primary	Change in carbamoylation surrogate	serum homocitrulline	From baseline to 6-month time points
Secondary	Change in cognition performance	Kaufman Assessment Battery for Children (KABC-II) for cognition testing score	From baseline to 6-month time points
Secondary	Change in motor proficiency	Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score	From baseline to 6-month time points