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

Biostime

Status: Unknown

Conditions: Health; Immune Functions; Growth

Treatments: Other: Infant formula supplemented with bovine milk Osteopontin; Other: Standard infant formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00970398

200816609

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 1 to 30 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Mothers 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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320 participants in 4 patient groups

Reference group

No Intervention group

Description:

Human milk breastfeeding

Control formula

Active Comparator group

Description:

Standard infant formula, with no Osteopontin supplemented.

Treatment:

Other: Standard infant formula

Formula with 50% Osteopontin

Active Comparator group

Description:

Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.

Treatment:

Other: Infant formula supplemented with bovine milk Osteopontin

Formula with 100% Osteopontin

Active Comparator group

Description:

Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.

Treatment:

Other: Infant formula supplemented with bovine milk Osteopontin