Adults 1 to 4, any sex, with Malnutrition or Manihot Species Poisoning. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mullen Scales of Early Learning (MSEL) Composite ScorePrimary· Month 6, month 12
The Mullen Scales of Early Learning (MSEL) assesses child developmental domains: visual reception, gross motor skills, fine motor skills, receptive language, and expressive language. A composite t-score derived from standardized t-scores of the four domains (excluding gross motor) provides a measure of g, the general measure of fluid intelligence thought to underlie general cognitive ability. The composite t-score ranges from 40 to 130. The t-scores have mean 100 and standard deviation 15 in the Western population. Higher scores reflect better outcome. Measure is applicable to children only, n
Technicians collected samples of urine on the same day as child assessments, so that they are contiguous with level of cyanide exposure from current poorly processed cassava. Urine thiocyanite levels in urine were measured in micromol per liter. The range was 0-1032, higher scores reflect worse outcome. Data collected from children only, not collected from caregivers.
Month 6
Group
Value
95% CI
MISC and WTM, Children
74.98
± 13.94
WTM Only, Children
139.00
± 20.17
Month 12
Group
Value
95% CI
MISC and WTM, Children
146.45
± 14.36
WTM Only, Children
108.91
± 20.18
Home Observation for the Measurement of the Environment (HOME) ScoreSecondary· Month 6, month 12
Home Observation for the Measurement of the Environment (HOME) composite measure designed to assess the quality and quantity of stimulation that the child is exposed to in their home environment. The Infant/Toddler version includes 45 items answered on the scale from 0=none to 3=good. A total HOME score was generated by summing item responses. Potential range is 0 to 135. Higher HOME scores indicate higher quality of home environment. Measure applies to children only.
Month 6
Group
Value
95% CI
MISC and WTM, Children
69.37
± 1.70
WTM Only, Children
67.61
± 2.42
Month 12
Group
Value
95% CI
MISC and WTM, Children
71.49
± 1.84
WTM Only, Children
68.07
± 2.42
Child Physical Growth: Length for Age Z-scoreSecondary· Month 6, month 12
Length for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1. Z-scores of -2 or below are often used to indicate stunting.
Month 6
Group
Value
95% CI
MISC and WTM, Children
-1.72
± 0.09
WTM Only, Children
-1.88
± 0.13
Month 12
Group
Value
95% CI
MISC and WTM, Children
-1.57
± 0.10
WTM Only, Children
-1.96
± 0.13
Child Physical Growth: Weight for Age Z-scoreSecondary· Month 6, month 12
Weight for age z-score was determined using the World Health Organization algorithm using child's length, sex, and age at the time of measurement. The world population mean is 0 with standard deviation 1.
The modified Hopkins Symptom Checklist was used to assess caregiver anxiety. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse anxiety. Measure applicable to caregiver only. Data were not collected from children.
The modified Hopkins Symptom Checklist was used to assess caregiver depressive symptoms. The instrument included 9 yes/no items, and the item responses were summed into the total score. The potential range was 0-9 with higher score indicating worse depressive symptoms. Measure applies to caregivers only, data were not collected from children.
Month 6
Group
Value
95% CI
MISC and WTM, Caregivers
2.21
± 0.29
WTM Only, Caregivers
4.25
± 0.42
Month 12
Group
Value
95% CI
MISC and WTM, Caregivers
2.45
± 0.32
WTM Only, Caregivers
4.18
± 0.42
Sponsor's own description
The proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the PI previously built in Uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the Democratic Republic of Congo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Michigan State University
Last refreshed: 24 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04036708.