None listed
Conditions
Interventions
Intervention1: Fortified sunflower oil: Sunflower oil fortified with nanoparticles of iron, folic acid, vitamin D and vitamin B12
Control Intervention1: Plain sunflower oil: Plain sunflower oil withou
Sponsors
Grand Challenges Canada
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy infants aged 4-6 weeks with birth weight of at least 2 kg 2.Living within study area for at least next 12 months 3.Parents agreeing to give written informed consent
Exclusion criteria
Exclusion criteria: 1.Babies with generalized skin disorder or skin infection 2.Babies with structural problem affecting more than 5% of their body surface area and likely to result in a defect in epidermal barrier function 3.Severely malnourished: weight for age z-score 4.Children with major congenital anomalies 5.Children with major birth or neonatal complications 6.Any other medical condition that in the opinion of investigator may interfere with the subjectâ??s participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in neurodevelopment evaluated on DASI (Developmental assessment score for Indian Infants) at 1 year of age.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of local and systemic adverse eventsTimepoint: 6 months and 12 months;Hb improvement in intervention group as compared to control group Timepoint: 6 months and 12 months;Improvement in 25-OH vitamin D3 levels in intervention group as compared to control group Timepoint: 6 months ad 12 months;Transferrin saturation levels at 6 months and 1 year of age Timepoint: 6 months and 12 months | — |
Countries
India
Contacts
Public ContactAshish Bavdekar
Department of Pediatrics and Vadu Rural Health Program, KEM Hospital Research Centre
Outcome results
None listed