Child Malnutrition Clinical Trial
Official title:
Acceptability of a Locally-Produced Multiple Micronutrient-Fortified Lipid-Based Nutrient Supplement (LNS) for Children Under Two Years in Cambodia
The purpose of this trial is to evaluate the acceptability of the LNS to women and their children aged 12-17 months in comparison to Corn Soy Blend++, and Sprinkles added to borbor (white rice porridge, which is the traditional weaning food in Cambodia). Acceptability will be assessed through a sensory test for caregivers, and by measuring children's consumption.
Status | Completed |
Enrollment | 92 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 9 Months to 23 Months |
Eligibility |
Inclusion Criteria: - Children aged 9-23 months and their caregivers - Have been eating solids for at least three months - Singletons - Normally nourished or only moderately malnourished (MUAC >115mm, WHZ score >-3) - Healthy (no ill-health in past three days) - No known food intolerances - Have not been using Sprinkles, CSB++ or similar supplementary foods or supplements - Informed signed consent of mother - Mothers are healthy Exclusion Criteria: - Children <9 months or >23mths - Not yet eating solid food for at least three months - Twins/multiples - Severely malnourished (MUAC< 115mm, WHZ score<3, bipedal pitting oedema). - Oedema and/or any medical complications at recruitment or illness requiring referral, or any ill health in past three days. - Known intolerances - Children enrolled in Sprinkles, CSB++ or similar program - No informed signed consent of caregiver - Medical complications or illness requiring referral at time of recruitment or previous two weeks |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Cambodia | IRD Cambodia | Phnom Penh |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherche pour le Developpement, Cambodia | Fisheries Post Harvest Technologies and Quality, Cambodia, UNICEF |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Child's consumption | How much of a given food the children consume | Within 15 minutes | No |
Secondary | Child's preference | Mothers' assessment of their child's ranked preference for the food | 3 days | No |
Secondary | Mother's ranking | Mother's ranked preference for the food | 1 session | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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