Effect of an Infant Formula on Infant Growth, Health and Immune Functions

Not Applicable

• Conditions: Health; Growth; Immune Functions
• Interventions: Other: Standard infant formula; Other: Infant formula supplemented with bovine milk Osteopontin

• 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2012-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-18
• Last Update Posted: 2013-04-22
• Study Completion: 2013-07

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

Arm && Interventions

Group	Intervention	Description
Control formula	Standard infant formula	Standard infant formula, with no Osteopontin supplemented.
Formula with 50% Osteopontin	Infant formula supplemented with bovine milk Osteopontin	Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.
Formula with 100% Osteopontin	Infant formula supplemented with bovine milk Osteopontin	Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.

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