None listed
Conditions
Brief summary
Low birth weight is an important risk factor for adult ischemic heart disease. Those born small-for-gestational-age (<10th percentile for gestational age and gender) are at the highest risk for adult cardiovascular disease. Children and adults born small for gestational age have increased arterial intima-media thickness – a noninvasive marker of subclinical atherosclerosis, the underlying disease process responsible for the majority of cardiovascular events. Birth weight is inversely associated with blood pressure – a major cardiovascular risk factor, in both children and adults. Published data from populations of children and young adults suggest that omega-3 fatty acid supplementation will have beneficial effects in reducing arterial intima-medial thickness and systolic blood pressure in children who were born small for gestational age. This hypothesis has not been tested in a randomized controlled trial. This study is designed to test the effectiveness of omega-3 fatty acid supplementation from 6 to 18 months of age in reducing aortic intima-media thickness and systolic blood pressure in children born small-for-gestational-age. The study will be conducted as an open label randomized controlled trial over a 1 year intervention (when the infant is 6-18 months old) where aortic intima media thickness and systolic blood pressure will be measured at recruitment, 6, 12 and 18 months of age.
Interventions
Participants will be randomized into groups to either the fish oil supplement (intervention) or no supplement (control) group from 6 months to 18 months of age.
The fish oil supplement will be provided to participants when infants are 6 months old in an encapsulated form containing 300 mg of omega-3 marine triglycerides (EPA 45mg, DHA 150mg), at a dose designed to achieve an omega-3 index of 8%, the optimum level for cardiovascular health. Parents/guardians will cleave the tail end of the capsul
Participants will be randomized into groups to either the fish oil supplement (intervention) or no supplement (control) group from 6 months to 18 months of age. The fish oil supplement will be provided to participants when infants are 6 months old in an encapsulated form containing 300 mg of omega-3 marine triglycerides (EPA 45mg, DHA 150mg), at a dose designed to achieve an omega-3 index of 8%, the optimum level for cardiovascular health. Parents/guardians will cleave the tail end of the capsule to dispense the liquid content into the infant's food or beverage. Compliance will be measured by assessing blood fatty acid status and empty supplement bottle return.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 2 Weeks
Healthy volunteers
Yes
Inclusion criteria
Infants born at term (>37 weeks gestation) that are small-for-gestational-age (birth weight<10th percentile for sex and gestational age).
Exclusion criteria
Multiple births, infants requiring surgery, illness in infant requiring hospitalization for more than 2 weeks, infants with significant neonatal disease, infants with chromosomal abnormalities or congenital malformations, fish oil contraindicated in mother.
Outcome results
None listed