Cassava Intervention Project

Ministry of Public Health, Democratic Republic of the Congo

Status: Completed

Conditions: Neurotoxicity Syndrome, Cyanide; Neurotoxicity Syndrome, Cyanate; Neurotoxicity Syndrome, Cassava; Neurotoxicity Syndrome, Thiocyanate

Treatments: Other: Non Inferiority WTM Interventional Trial

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03157336

FWA00017202

R01ES019841 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Peer-led Intervention

Experimental group

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.

Treatment:

Other: Non Inferiority WTM Interventional Trial

Specialist-led Intervention

Experimental group

Description:

Specialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial..

Treatment:

Other: Non Inferiority WTM Interventional Trial