Growth Clinical Trial
Official title:
Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Verified date | April 2013 |
Source | Biostime, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Biostime, Inc. | Arla Foods, Children's Hospital of Fudan University, University of California, Davis, University of Illinois at Urbana-Champaign |
China,
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
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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