Effect of an Infant Formula on Infant Growth, Health and Immune Functions
Not Applicable
- Conditions
- HealthGrowthImmune Functions
- Registration Number
- NCT00970398
- Lead Sponsor
- Biostime, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
- Healthy, 19-40 years of age
- Plan to exclusively breast-fed or formula-fed
Infants
Exclusion Criteria
- Gestational age < 37 or > 42 weeks
- Birth weight < 2.5kg or > 4 kg
- Having congenital diseases
- Having birth Asphyxia
- Having birth infections
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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. 1, 4, and 6 postnatal months
- Secondary Outcome Measures
Name Time Method Anthropometric parameters: body length, body weight, and head circumferences at each visit. 1, 2, 3, 4, 5, and 6 postnatal months Dietary, stool consistency and well being recorded by 3 day questionnaires 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. 1, 2, 3, 4, 5, and 6 postnatal months
Trial Locations
- Locations (1)
Children's Hospital of Fudan University
🇨🇳Shanghai, China
Children's Hospital of Fudan University🇨🇳Shanghai, China