Effect of an Infant Formula on Infant Growth, Health and Immune Functions
NCT ID: NCT00970398
Last Updated: 2013-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
320 participants
INTERVENTIONAL
2009-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Reference group
Human milk breastfeeding
No interventions assigned to this group
Control formula
Standard infant formula, with no Osteopontin supplemented.
Standard infant formula
Infant formula without supplementation of bovine milk Osteopontin
Formula with 50% Osteopontin
Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.
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.
Formula with 100% Osteopontin
Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.
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.
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Plan to exclusively breast-fed or formula-fed
Exclusion Criteria
* Birth weight \< 2.5kg or \> 4 kg
* Having congenital diseases
* Having birth Asphyxia
* Having birth infections
1 Day
30 Days
ALL
Yes
Sponsors
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Arla Foods
INDUSTRY
Children's Hospital of Fudan University
OTHER
University of California, Davis
OTHER
University of Illinois at Urbana-Champaign
OTHER
Biostime, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongmei Peng, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Bo Lonnerdal, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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Children's Hospital of Fudan University
Shanghai, , China
Countries
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References
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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. doi: 10.1126/science.287.5454.860.
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. doi: 10.1111/j.1365-2249.2004.02549.x.
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. doi: 10.1128/JVI.79.6.3509-3516.2005.
Lonnerdal B, Kvistgaard AS, Peerson JM, Donovan SM, Peng YM. Growth, Nutrition, and Cytokine Response of Breast-fed Infants and Infants Fed Formula With Added Bovine Osteopontin. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):650-7. doi: 10.1097/MPG.0000000000001005.
Other Identifiers
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200816609
Identifier Type: -
Identifier Source: org_study_id
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