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Effect of an Infant Formula on Infant Growth, Health and Immune Functions
This study is not yet open for participant recruitment.
Verified by Fudan University, September 2009
First Received: September 1, 2009   No Changes Posted
Sponsor: Fudan University
Collaborators: Biostime, Inc. (Guangzhou)
Arla amba, Denmark
University of California, Davis
University of Illinois at Urbana-Champaign
Information provided by: Fudan University
ClinicalTrials.gov Identifier: NCT00970398
  Purpose

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. 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.


Condition Intervention Phase
Healthy
 Dietary Supplement: Supplementation of bovine milk Osteopontin to infant formula
 Phase IV

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Safety/Efficacy Study
Official Title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune Functions

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Infant and Toddler Nutrition
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Evaluate infant growth, health and immune functions with formula supplemented with bovine milk Osteopontin in comparison with breast-fed infants. [ Time Frame: 1, 4, and 6 months of age ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: September 2009
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Breastfed group: Active Comparator Dietary Supplement: Supplementation of bovine milk Osteopontin to infant formula
Infant formula supplemented with bovine milk osteopontin at 0%, 50% and 100% levels of that of breast milk
Control formula: Sham Comparator
Formula group with 0% osteopontin
Dietary Supplement: Supplementation of bovine milk Osteopontin to infant formula
Infant formula supplemented with bovine milk osteopontin at 0%, 50% and 100% levels of that of breast milk
Formula with 50% Osteopontin: Experimental Dietary Supplement: Supplementation of bovine milk Osteopontin to infant formula
Infant formula supplemented with bovine milk osteopontin at 0%, 50% and 100% levels of that of breast milk
Formula with 100% Osteopontin: Experimental Dietary Supplement: Supplementation of bovine milk Osteopontin to infant formula
Infant formula supplemented with bovine milk osteopontin at 0%, 50% and 100% levels of that of breast milk

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Mothers Inclusion Criteria:

  • Singleton conception
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970398

Contacts
Contact: Yongmei Peng +86-21-6493-1990 ympeng99@yahoo.com.cn

Locations
China
Children's Hospital of Fudan University
Shanghai, China, 201102
Sponsors and Collaborators
Fudan University
Biostime, Inc. (Guangzhou)
Arla amba, Denmark
University of California, Davis
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Bo Lonnerdal, Ph.D. University of California, Davis
  More Information

Publications:
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.
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.
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.

Responsible Party: Children's Hospital of Fudan University ( Yongmei Peng )
Study ID Numbers: 200816609
Study First Received: September 1, 2009
Last Updated: September 1, 2009
ClinicalTrials.gov Identifier: NCT00970398     History of Changes
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Infant formula
Bovine milk Osteopontin
growth
health
 immune functions
Infant
2 weeks to 6 months

ClinicalTrials.gov processed this record on February 08, 2010



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