Overview

This trial is active, not recruiting.

Conditions health, growth, immune functions
Treatments infant formula supplemented with bovine milk osteopontin, standard infant formula
Sponsor Biostime, Inc.
Collaborator Arla Foods
Start date September 2009
End date September 2012
Trial size 320 participants
Trial identifier NCT00970398, 200816609

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.

United States No locations recruiting
Other Countries No locations recruiting

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
Arm
(No Intervention)
Human milk breastfeeding
(Active Comparator)
Standard infant formula, with no Osteopontin supplemented.
standard infant formula Lactopontin
Infant formula without supplementation of bovine milk Osteopontin
(Active Comparator)
Infant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk.
infant formula supplemented with bovine milk osteopontin Lactopontin
Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.
(Active Comparator)
Infant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk.
infant formula supplemented with bovine milk osteopontin Lactopontin
Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.

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.
time frame: 1, 4, and 6 postnatal months

Secondary Outcomes

Measure
Anthropometric parameters: body length, body weight, and head circumferences at each visit.
time frame: 1, 2, 3, 4, 5, and 6 postnatal months
Dietary, stool consistency and well being recorded by 3 day questionnaires
time frame: 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.
time frame: 1, 2, 3, 4, 5, and 6 postnatal months

Eligibility Criteria

Male or female participants up to 30 days old.

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

Additional Information

Official title Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
Principal investigator Yongmei Peng, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Biostime, Inc..