None listed
Conditions
Brief summary
The project is a cluster randomized controlled community-based study to evaluate the effectiveness of providing infants 6-11 months of age with daily micronutrient powders (called “Sprinkles”), in addition to nutrition education. he study will be conducted in one health operational district with 20 health centres. Nutrition education will be delivered at all health centres through health centre staff and village health support groups to caregivers. Infants in the intervention group (ten randomly selected health centre catchment areas) will receive multi-micronutrients daily from aged 6 until 11 months plus infant and young child feeding education versus the active control group (the other 10 health cetnre catchment areas) receiving infant & young child feeing education alone. Infants will be followed until 18 months of age to determine the extent to which the additional micronutrients produce lasting benefits over this critical age range. The study will also test the operational feasibility of delivering micronutrient “Sprinkles” with nutrition education through existing government health services.). Blood tests, anthropometry and other information will be collected from 1200 children (600 infants in each arm) who will be randomly selected from a complete listing of children, total expected sample size of 3600 infants (1800 in each arm) at baseline (aged 6 months), after 6 months of intervention (aged 12 months) and 6 month post intervention (aged 18 months). A further round of data collection will be done to follow up the children 12 months post intervention (aged 24 months)
Interventions
Infant and young child feeding practices promotion through one on one and group education by village health volunteers using behaviour change communication including flipcharts; multiple micronutrient powder in-home fortification (Sprinkles formulation: Iron (microencapsulated ferrous fumarate) 12.5mg; Zinc (Zinc gluconate) 10mg; Vitamin A (retinol acetate) 300µg; Iodine 90µg; Vitamin B1 0.5mg; Vitamin B2 0.5mg; Vitamin B6 0.5mg; Vitamin B12 0.9µg; Niacin 6mg; Folate (folic acid) 160µg; Vitamin C (ascorbic acid) 30mg; Copper 0.3mg; Vitamin D 5µg; Vitamin E 6 IU.) once daily, sprinkled on complementary food, for 6 months.
Sponsors
Study design
Eligibility
Inclusion criteria
All 6 month old infants(rolling recruitment from March 2008- August 2008) residing in Svay Rieng Operational District, Svay Rieng Province, Cambodia
Exclusion criteria
Severe acute malnutrition (<-3 Z-score weight for length) Severe anaemia (<7 g/dL)