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

Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970398

Enrollment

320

Registered

2009-09-02

Start date

2009-09-30

Completion date

2013-07-31

Last updated

2013-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Growth, Immune Functions

Keywords

Infant formula, Bovine milk Osteopontin, growth, health, immune functions

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.

Interventions

OTHERInfant formula supplemented with bovine milk Osteopontin

Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.

OTHERStandard infant formula

Infant formula without supplementation of bovine milk Osteopontin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 30 Days

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026