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Completed

NCT Number: NCT03157336

Cassava Intervention Project

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.

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Key information

Conditions

Neurotoxicity Syndrome, Cassava Chemically-Induced Disorders Nervous System Diseases Neurotoxicity Syndrome, Cyanate Neurotoxicity Syndrome, Cyanide Neurotoxicity Syndrome, Thiocyanate Neurotoxicity Syndromes Poisoning

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INRB

Kinshasa, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ministry of Public Health, Democratic Republic of the Congo

Other Gov

Collaborators

  • Michigan State University
  • National Institute of Environmental Health Sciences (NIEHS)
  • National Institutes of Health (NIH)
  • Oregon Health and Science University
  • University of Kinshasa

Registry information

Official study title

Toxicodietary and Genetic Determinants of Susceptibility to Neurodegeneration

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 17, 2017
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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