HealthNCT00970398
Effect of an Infant Formula on Infant Growth, Health and Immune Functions
A study testing Infant formula supplemented with bovine milk Osteopontin and Standard infant formula in people with Health and Growth, run by Biostime, Inc. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Health, Growth, Immune Functions
- What is being tested?
- Infant formula supplemented with bovine milk Osteopontin and Standard infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
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.
Read the 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.
- Conditions
- Health, Growth, Immune Functions
- Being tested
- Infant formula supplemented with bovine milk Osteopontin, Standard infant formula
- Keywords
- Infant formula, Bovine milk Osteopontin, growth, health, immune functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula supplemented with bovine milk OsteopontinOther
Also called Lactopontin
Infant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively.
Standard infant formulaOther
Also called Lactopontin
Infant formula without supplementation of bovine milk Osteopontin
| Study group | Role | What they receive |
|---|---|---|
| Reference group | No intervention | Human milk breastfeeding |
| Control formula | Active comparator | Standard infant formula, with no Osteopontin supplemented. Receives: 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. Receives: 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. Receives: Other: Infant formula supplemented with bovine milk Osteopontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 4, and 6 postnatal months
Secondary outcomes (3)
Anthropometric parameters: body length, body weight, and head circumferences at each visit.
Measured: 1, 2, 3, 4, 5, and 6 postnatal months
Dietary, stool consistency and well being recorded by 3 day questionnaires
Measured: 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.
Measured: 1, 2, 3, 4, 5, and 6 postnatal months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biostime, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Arla Foods, Children's Hospital of Fudan University, University of California, Davis, University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
- Investigators
- Yongmei Peng, M.D., Principal investigator, Children's Hospital of Fudan UniversityBo Lonnerdal, Ph.D., Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970398
- Sponsor's protocol ID
- 200816609
- Status last verified
- Apr 2013
- First submitted
- 1 Sep 2009
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 10657301Nagatomo 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.
PubMed 15373904Rollo 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.
PubMed 15731245Lonnerdal 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.
PubMed 26465791
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infant Formula With Bovine Milk Osteopontin on Infant Growth, Health and Immune functions-a Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT00970398
- Acronym / sponsor ID
- 200816609
- Conditions
- Health, Growth, Immune Functions
- Keywords
- Infant formula, Bovine milk Osteopontin, growth, health, immune functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Biostime, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Arla Foods, Children's Hospital of Fudan University, University of California, Davis, University of Illinois at Urbana-Champaign
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reference group | No intervention | –Human milk breastfeeding |
| Control formula | Active comparator | Other: Standard infant formulaStandard infant formula, with no Osteopontin supplemented. |
| Formula with 50% Osteopontin | Active comparator | Other: Infant formula supplemented with bovine milk OsteopontinInfant formula supplemented with bovine milk Osteopontin at 50% level of that of breast milk. |
| Formula with 100% Osteopontin | Active comparator | Other: Infant formula supplemented with bovine milk OsteopontinInfant formula supplemented with bovine milk Osteopontin at 100% level of that of breast milk. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant formula supplemented with bovine milk OsteopontinAlso: LactopontinInfant formula supplemented with bovine milk osteopontin at 50% and 100% levels of that of breast milk respectively. | Other | Formula with 100% Osteopontin, Formula with 50% Osteopontin |
| Standard infant formulaAlso: LactopontinInfant formula without supplementation of bovine milk Osteopontin | Other | Control formula |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Background: PubMed 10657301Ashkar 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.
- Background: PubMed 15373904Nagatomo 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.
- Background: PubMed 15731245Rollo 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.
- Derived from this study: PubMed 26465791Lonnerdal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongmei Peng, M.D. principal investigator
Children's Hospital of Fudan University
Bo Lonnerdal, Ph.D. principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula supplemented with bovine milk Osteopontin and Standard infant formula in people with Health and Growth, run by Biostime, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00970398, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.