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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Arla Foods
Children's Hospital of Fudan Univeristy
University of California, Davis
University of Illinois at Urbana-Champaign
Information provided by (Responsible Party):
Biostime, Inc.
ClinicalTrials.gov Identifier:
NCT00970398
First received: September 1, 2009
Last updated: April 18, 2013
Last verified: April 2013
  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.


Condition Intervention
Health
Growth
Immune Functions
Other: Infant formula supplemented with bovine milk Osteopontin
Other: Standard infant formula

Study Type: Interventional
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
Official Title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by Biostime, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: 1, 4, and 6 postnatal months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometric parameters: body length, body weight, and head circumferences at each visit. [ Time Frame: 1, 2, 3, 4, 5, and 6 postnatal months ] [ Designated as safety issue: Yes ]
  • Dietary, stool consistency and well being recorded by 3 day questionnaires [ Time Frame: 1, 2, 3, 4, 5, and 6 postnatal months ] [ Designated as safety issue: Yes ]
  • Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability. [ Time Frame: 1, 2, 3, 4, 5, and 6 postnatal months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: September 2009
Estimated Study Completion Date: July 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Reference group
Human milk breastfeeding
Active Comparator: Control formula
Standard infant formula, with no Osteopontin supplemented.
Other: Standard infant formula
Infant formula without supplementation of bovine milk Osteopontin
Other Name: Lactopontin
Active Comparator: Formula with 50% Osteopontin
Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.
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.
Other Name: Lactopontin
Active Comparator: Formula with 100% Osteopontin
Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.
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.
Other Name: Lactopontin

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970398

Locations
China
Children's Hospital of Fudan University
Shanghai, China, 201102
Sponsors and Collaborators
Biostime, Inc.
Arla Foods
Children's Hospital of Fudan Univeristy
University of California, Davis
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Yongmei Peng, M.D. Children's Hospital of Fudan University
Principal Investigator: Bo Lonnerdal, Ph.D. University of California, Davis