The specific objectives of this study are to evaluate the effects of bovine milk osteopontin added to infant formula on infant growth, health and immune functions.
Breast-fed infants will be used as a reference group and formula-fed infants will be fed control formula or the same formula supplemented with Osteopontin at a concentration 50% or 100% of that of breast milk. The hypothesis is that supplementation of bovine milk Osteopontin in infant formula will have positive effects on infant growth, health and immune functions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
320
Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.
Infant formula without supplementation of bovine milk Osteopontin
Children's Hospital of Fudan University
Shanghai, China
Concentrations of immune cells and cytokines of IL-6, IL-10, and IL-12 in infant's blood samples will be measured to evaluate immune functions.
Time frame: 1, 4, and 6 postnatal months
Anthropometric parameters: body length, body weight, and head circumferences at each visit.
Time frame: 1, 2, 3, 4, 5, and 6 postnatal months
Dietary, stool consistency and well being recorded by 3 day questionnaires
Time frame: 1, 2, 3, 4, 5, and 6 postnatal months
Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability.
Time frame: 1, 2, 3, 4, 5, and 6 postnatal months
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