Neurotoxicity Syndrome, CassavaNCT03157336
Cassava Intervention Project
A study testing Non Inferiority WTM Interventional Trial in people with Neurotoxicity Syndrome, Cassava and Neurotoxicity Syndrome, Cyanate, run by Ministry of Public Health, Democratic Republic of the Congo at 1 site in Democratic Republic of the Congo.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide
- What is being tested?
- Non Inferiority WTM Interventional Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 30 Jul 2017to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of seizures
- History of cerebral malaria
- History of retroviral (HIV-HTLV) infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration
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.
Read the 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.
- Conditions
- Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide, Neurotoxicity Syndrome, Thiocyanate
- Being tested
- Non Inferiority WTM Interventional Trial
- Keywords
- Cassava, Konzo, Cyanide, Cyanate, Thiocyanate, Carbamoylation, Isoprostanes, Oxidative Damage
- Medical subject headings
- Neurotoxicity Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Inferiority WTM Interventional TrialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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.. Receives: Other: Non Inferiority WTM Interventional Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in food cyanogenic exposure
Cassava cyanogenic content
Measured: From baseline to 6-month time points
Change in internal cyanogenic exposure
Urinary concentrations of thiocyanate (U-SCN)
Measured: From baseline to 6-month time points
Change in oxidation damage
Serum isoprostanes
Measured: From baseline to 6-month time points
Change in carbamoylation
serum albumin peptidic carbamoylation
Measured: From baseline to 6-month time points
Change in carbamoylation surrogate
serum homocitrulline
Measured: From baseline to 6-month time points
Secondary outcomes (2)
Change in cognition performance
Kaufman Assessment Battery for Children (KABC-II) for cognition testing score
Measured: From baseline to 6-month time points
Change in motor proficiency
Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score
Measured: From baseline to 6-month time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start30 Jul 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotoxicity Syndrome, CassavaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the Congo
- Sponsor type
- Other government
- Collaborators
- National Institutes of Health (NIH), Oregon Health and Science University, Michigan State University, University of Kinshasa, National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Desire Tshala-Katumbay, Ministry of Public Health, Democratic Republic of the Congo
- Investigators
- Mumba Ngoyi, Study director, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157336
- Sponsor's protocol ID
- FWA00017202
- Other IDs
- R01ES019841
- Status last verified
- Jun 2022
- First submitted
- 12 May 2017
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration
- ClinicalTrials.gov ID
- NCT03157336
- Acronym / sponsor ID
- FWA00017202
- Conditions
- Neurotoxicity Syndrome, Cassava, Neurotoxicity Syndrome, Cyanate, Neurotoxicity Syndrome, Cyanide, Neurotoxicity Syndrome, Thiocyanate
- Keywords
- Cassava, Konzo, Cyanide, Cyanate, Thiocyanate, Carbamoylation, Isoprostanes, Oxidative Damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Ministry of Public Health, Democratic Republic of the CongoOther government
- Collaborators
- National Institutes of Health (NIH), Oregon Health and Science University, Michigan State University, University of Kinshasa, National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Peer-led Intervention | Experimental | Other: Non Inferiority WTM Interventional TrialPeers (community women in leading roles) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial. |
| Specialist-led Intervention | Experimental | Other: Non Inferiority WTM Interventional TrialSpecialists (nutritionists) training other women in the wetting method for safe processing of cassava in a non-inferiority intervention trial.. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- History of seizures
- History of cerebral malaria
- History of retroviral (HIV-HTLV) infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Inferiority WTM Interventional TrialThe 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. | Other | Peer-led Intervention, Specialist-led Intervention |
Primary outcome
Change in food cyanogenic exposure
Time frame: From baseline to 6-month time points
Cassava cyanogenic content
Change in internal cyanogenic exposure
Time frame: From baseline to 6-month time points
Urinary concentrations of thiocyanate (U-SCN)
Change in oxidation damage
Time frame: From baseline to 6-month time points
Serum isoprostanes
Change in carbamoylation
Time frame: From baseline to 6-month time points
serum albumin peptidic carbamoylation
Change in carbamoylation surrogate
Time frame: From baseline to 6-month time points
serum homocitrulline
2 secondary outcomes
Change in cognition performance
Time frame: From baseline to 6-month time points
Change in motor proficiency
Time frame: From baseline to 6-month time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mumba Ngoyi study director
Ministry of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Inferiority WTM Interventional Trial in people with Neurotoxicity Syndrome, Cassava and Neurotoxicity Syndrome, Cyanate, run by Ministry of Public Health, Democratic Republic of the Congo at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in food cyanogenic exposure (time frame: From baseline to 6-month time points). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.