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Cassava Intervention Project

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ClinicalTrials.gov Identifier: NCT03157336
Recruitment Status : Active, not recruiting
First Posted : May 17, 2017
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Oregon Health and Science University
Michigan State University
University of Kinshasa
National Institute of Environmental Health Sciences (NIEHS)
Information provided by (Responsible Party):
Desire Tshala-Katumbay, Ministry of Public Health, Democratic Republic of the Congo

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.

Condition or disease Intervention/treatment Phase
Neurotoxicity Syndrome, Cassava Neurotoxicity Syndrome, Cyanate Neurotoxicity Syndrome, Cyanide Neurotoxicity Syndrome, Thiocyanate Other: Non Inferiority WTM Interventional Trial Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration
Actual Study Start Date : July 30, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peer-led Intervention
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
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.

Experimental: Specialist-led Intervention
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
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.




Primary Outcome Measures :
  1. Change in food cyanogenic exposure [ Time Frame: From baseline to 6-month time points ]
    Cassava cyanogenic content

  2. Change in internal cyanogenic exposure [ Time Frame: From baseline to 6-month time points ]
    Urinary concentrations of thiocyanate (U-SCN)

  3. Change in oxidation damage [ Time Frame: From baseline to 6-month time points ]
    Serum isoprostanes

  4. Change in carbamoylation [ Time Frame: From baseline to 6-month time points ]
    serum albumin peptidic carbamoylation

  5. Change in carbamoylation surrogate [ Time Frame: From baseline to 6-month time points ]
    serum homocitrulline


Secondary Outcome Measures :
  1. Change in cognition performance [ Time Frame: From baseline to 6-month time points ]
    Kaufman Assessment Battery for Children (KABC-II) for cognition testing score

  2. Change in motor proficiency [ Time Frame: From baseline to 6-month time points ]
    Motor proficiency Bruininks/Oseretsky Testing (BOT-2) score



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03157336


Locations
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Congo, The Democratic Republic of the
INRB
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
Ministry of Public Health, Democratic Republic of the Congo
National Institutes of Health (NIH)
Oregon Health and Science University
Michigan State University
University of Kinshasa
National Institute of Environmental Health Sciences (NIEHS)
Investigators
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Study Director: Mumba Ngoyi Netherlands: Ministry of Health, Welfare and Sports

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Responsible Party: Desire Tshala-Katumbay, Head Complex Morbidity Unit, Ministry of Public Health, Democratic Republic of the Congo
ClinicalTrials.gov Identifier: NCT03157336     History of Changes
Other Study ID Numbers: FWA00017202
R01ES019841 ( U.S. NIH Grant/Contract )
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Desire Tshala-Katumbay, Ministry of Public Health, Democratic Republic of the Congo:
Cassava
Konzo
Cyanide
Cyanate
Thiocyanate
Carbamoylation
Isoprostanes
Oxidative Damage
Additional relevant MeSH terms:
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Neurotoxicity Syndromes
Syndrome
Disease
Pathologic Processes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders