CompletedNot Applicable

Cassava Intervention Project

Democratic Republic of the Congo1,200 participantsStarted 2017-07-30

Plain-language 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.

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in food cyanogenic exposure

Timeframe: From baseline to 6-month time points

Change in internal cyanogenic exposure

Timeframe: From baseline to 6-month time points

Change in oxidation damage

Timeframe: From baseline to 6-month time points

Change in carbamoylation

Timeframe: From baseline to 6-month time points

Change in carbamoylation surrogate

Timeframe: From baseline to 6-month time points

Trial details

NCT IDNCT03157336

SponsorMinistry of Public Health, Democratic Republic of the Congo

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-06-01

View on ClinicalTrials.gov More Neurotoxicity Syndrome, Cassava trials

Plain-language summary

Who can participate

Age range

5 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in food cyanogenic exposure

Timeframe: From baseline to 6-month time points

Change in internal cyanogenic exposure

Timeframe: From baseline to 6-month time points

Change in oxidation damage

Timeframe: From baseline to 6-month time points

Change in carbamoylation

Timeframe: From baseline to 6-month time points

Change in carbamoylation surrogate

Timeframe: From baseline to 6-month time points