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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00970398
Other study ID # 200816609
Secondary ID
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


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
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