Cassava Intervention Project

NCT03157336 | Completed

• 2 other identifiers: FWA00017202R01ES019841
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cassava; Konzo; Cyanide; Cyanate; Thiocyanate; Carbamoylation; Isoprostanes; Oxidative Damage

Outcome Measures

Primary Outcomes (5)

• Change in food cyanogenic exposure

  Cassava cyanogenic content

  From baseline to 6-month time points

• Change in internal cyanogenic exposure

  Urinary concentrations of thiocyanate (U-SCN)

  From baseline to 6-month time points

• Change in oxidation damage

  Serum isoprostanes

  From baseline to 6-month time points

• Change in carbamoylation

  serum albumin peptidic carbamoylation

  From baseline to 6-month time points

• Change in carbamoylation surrogate

  serum homocitrulline

  From baseline to 6-month time points

Secondary Outcomes (2)

• Change in cognition performance

  From baseline to 6-month time points

• Change in motor proficiency

  From baseline to 6-month time points

Study Arms (2)

Peer-led Intervention

EXPERIMENTAL

Peers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.

Other: Non Inferiority WTM Interventional Trial

Specialist-led Intervention

EXPERIMENTAL

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

Other: Non Inferiority WTM Interventional Trial

Interventions

Non Inferiority WTM Interventional Trial OTHER

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.

Peer-led Intervention; Specialist-led Intervention

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• History of seizures
• History of cerebral malaria
• History of retroviral (HIV-HTLV) infections

Sponsors & Collaborators

• Ministry of Public Health, Democratic Republic of the Congo: lead
• National Institutes of Health (NIH): collaborator
• Oregon Health and Science University: collaborator
• Michigan State University: collaborator
• University of Kinshasa: collaborator
• National Institute of Environmental Health Sciences (NIEHS): collaborator

Study Sites (1)

INRB

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Mumba Ngoyi

  Ministry of Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Complex Morbidity Unit

Model Details: 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)

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 17, 2017
• Study Start: July 30, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)