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

April 18, 2013 updated by: Biostime, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Lactopontin

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 1, 4, and 6 postnatal months
1, 4, and 6 postnatal months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biostime, Inc.

Collaborators

University of California, Davis
University of Illinois at Urbana-Champaign
Children's Hospital of Fudan University
Arla Foods

Investigators

  • Principal Investigator: Yongmei Peng, M.D., Children's Hospital of Fudan University
  • Principal Investigator: Bo Lonnerdal, Ph.D., University of California, Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2012

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 22, 2013

Last Update Submitted That Met QC Criteria

April 18, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200816609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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