Clinical trial NCT00970398: Effect of an Infant Formula on Infant Growth, Health and Immune Functions
Official title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health
Growth
Immune Functions
Keywords: Infant formula
Bovine milk Osteopontin
growth
health
immune functions
Lead sponsor: Biostime, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Arla Foods
name: Children's Hospital of Fudan University
name: University of California, Davis
name: University of Illinois at Urbana-Champaign
First posted: 2009-09-02
Enrollment: 320
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1, 4, and 6 postnatal months
Secondary outcomes:
measure: Anthropometric parameters: body length, body weight, and head circumferences at each visit.
timeFrame: 1, 2, 3, 4, 5, and 6 postnatal months
measure: Dietary, stool consistency and well being recorded by 3 day questionnaires
timeFrame: 1, 2, 3, 4, 5, and 6 postnatal months
measure: Adverse events and concomitant medications recorded by heath forms as a measure of safety and tolerability.
timeFrame: 1, 2, 3, 4, 5, and 6 postnatal months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Yongmei Peng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Bo Lonnerdal, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1111/j.1365-2249.2004.02549.x.
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. doi: 10.1128/JVI.79.6.3509-3516.2005.
citation: 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.