NCT00970398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

September 1, 2009

Last Update Submit

April 18, 2013

Conditions

HealthGrowthImmune Functions

Keywords

Infant formulaBovine milk Osteopontingrowthhealthimmune functions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Anthropometric parameters: body length, body weight, and head circumferences at each visit.

    1, 2, 3, 4, 5, and 6 postnatal months

  • Dietary, stool consistency and well being recorded by 3 day questionnaires

    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.

    1, 2, 3, 4, 5, and 6 postnatal months

Study Arms (4)

Reference group

NO INTERVENTION

Human milk breastfeeding

Control formula

ACTIVE COMPARATOR

Standard infant formula, with no Osteopontin supplemented.

Other: Standard infant formula

Formula with 50% Osteopontin

ACTIVE COMPARATOR

Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.

Other: Infant formula supplemented with bovine milk Osteopontin

Formula with 100% Osteopontin

ACTIVE COMPARATOR

Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.

Other: Infant formula supplemented with bovine milk Osteopontin

Interventions

Infant formula supplemented with bovine milk OsteopontinOTHER

Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.

Also known as: Lactopontin
Formula with 100% OsteopontinFormula with 50% Osteopontin
Standard infant formulaOTHER

Infant formula without supplementation of bovine milk Osteopontin

Also known as: Lactopontin
Control formula

Eligibility Criteria

Age1 Day - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy, 19-40 years of age
  • Plan to exclusively breast-fed or formula-fed

You may not qualify if:

  • Gestational age \< 37 or \> 42 weeks
  • Birth weight \< 2.5kg or \> 4 kg
  • Having congenital diseases
  • Having birth Asphyxia
  • Having birth infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Related Publications (4)

  • 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.

    PMID: 10657301BACKGROUND

  • 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.

    PMID: 15373904BACKGROUND

  • 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.

    PMID: 15731245BACKGROUND

  • 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.

    PMID: 26465791DERIVED

Study Officials

  • Yongmei Peng, M.D.

    Children's Hospital of Fudan University

    PRINCIPAL INVESTIGATOR

  • Bo Lonnerdal, Ph.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

July 1, 2013

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations

CN(1)