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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00970398
• Other study ID #: 200816609
• Status: Active, not recruiting
• Phase: N/A
• First received: September 1, 2009
• Last updated: April 18, 2013
• Start date: September 2009
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Biostime, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: July 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Growth
• Health
• Immune Functions

Intervention

Other:
• Infant formula supplemented with bovine milk Osteopontin
Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.
• Standard infant formula
Infant formula without supplementation of bovine milk Osteopontin

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Biostime, Inc.	Arla Foods, Children's Hospital of Fudan University, University of California, Davis, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

China, 

References & Publications (3)

Ashkar S, Weber GF, Panoutsakopoulou V, Sanchirico ME, Jansson M, Zawaideh S, Rittling SR, Denhardt DT, Glimcher MJ, Cantor H. Eta-1 (osteopontin): an early component of type-1 (cell-mediated) immunity. Science. 2000 Feb 4;287(5454):860-4. — View Citation

Nagatomo T, Ohga S, Takada H, Nomura A, Hikino S, Imura M, Ohshima K, Hara T. Microarray analysis of human milk cells: persistent high expression of osteopontin during the lactation period. Clin Exp Immunol. 2004 Oct;138(1):47-53. — View Citation

Rollo EE, Hempson SJ, Bansal A, Tsao E, Habib I, Rittling SR, Denhardt DT, Mackow ER, Shaw RD. The cytokine osteopontin modulates the severity of rotavirus diarrhea. J Virol. 2005 Mar;79(6):3509-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Anthropometric parameters: body length, body weight, and head circumferences at each visit.		1, 2, 3, 4, 5, and 6 postnatal months	Yes
Secondary	Dietary, stool consistency and well being recorded by 3 day questionnaires		1, 2, 3, 4, 5, and 6 postnatal months	Yes
Secondary	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	Yes