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

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ClinicalTrials.gov Identifier: NCT00970398
Recruitment Status : Unknown
Verified April 2013 by Biostime, Inc..
Recruitment status was:  Active, not recruiting
First Posted : September 2, 2009
Last Update Posted : April 22, 2013
Sponsor:
Collaborators:
Arla Foods
Children's Hospital of Fudan University
University of California, Davis
University of Illinois at Urbana-Champaign
Information provided by (Responsible Party):
Biostime, Inc.

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Primary Completion Date : September 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Anthropometric parameters: body length, body weight, and head circumferences at each visit. [ Time Frame: 1, 2, 3, 4, 5, and 6 postnatal months ]
  2. Dietary, stool consistency and well being recorded by 3 day questionnaires [ Time Frame: 1, 2, 3, 4, 5, and 6 postnatal months ]
  3. 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 ]


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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970398


Locations
China
Children's Hospital of Fudan University
Shanghai, China, 201102
Sponsors and Collaborators
Biostime, Inc.
Arla Foods
Children's Hospital of Fudan University
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