HealthyNCT02587702
Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants
A study testing β-Palmitate Content and β-Palmitate Content Naturely in Human Milk in people with Healthy, run by Beingmate Baby & Child Food Co Ltd . at 1 site in China.
Trial summary
The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- β-Palmitate Content and β-Palmitate Content Naturely in Human Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Dec 2015
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy full term infants
Who cannot join
- experienced congenital or chromosomal disorders
- neonatal morbidities, or metabolic illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai
Fei Bei, Master, 86-21-38625778, Fionabei@163.com
About this study
The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants
- Conditions
- Healthy
- Being tested
- β-Palmitate Content, Placebo, β-Palmitate Content Naturely in Human Milk
- Keywords
- Term Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-Palmitate ContentOther
PlaceboOther
β-Palmitate Content Naturely in Human MilkOther
| Study group | Role | What they receive |
|---|---|---|
| Improved Infant Formula Group | Experimental | Containing β-Palmitate Content Receives: Other: β-Palmitate Content |
| General Infant Formula Group | Placebo comparator | Excluding β-Palmitate Content Receives: Other: Placebo |
| Human Milk Group | Active comparator | Containing β-Palmitate Content Naturely in Human Milk Receives: Other: β-Palmitate Content Naturely in Human Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content of fatty acids
Measured: 3 years
Content of calcium and magnesium
Measured: 3 years
Secondary outcomes (3)
Anthropometric measurements
Index of anthropometric measurements contains weight,height and head circumference.
Measured: 3 years
Stool characteristics assessed via stool frequency
Measured: 3 years
Stool characteristics assessed via stool consistency
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJun 2013
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587702
- Sponsor's protocol ID
- RDM2012002
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants
- ClinicalTrials.gov ID
- NCT02587702
- Acronym / sponsor ID
- RDM2012002
- Conditions
- Healthy
- Keywords
- Term Infants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beingmate Baby & Child Food Co Ltd .University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (estimated)
- First posted
- 27 Oct 2015 (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 purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improved Infant Formula Group | Experimental | Other: β-Palmitate ContentContaining β-Palmitate Content |
| General Infant Formula Group | Placebo comparator | Other: PlaceboExcluding β-Palmitate Content |
| Human Milk Group | Active comparator | Other: β-Palmitate Content Naturely in Human MilkContaining β-Palmitate Content Naturely in Human Milk |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy full term infants
Key exclusion criteria (2 listed)
- experienced congenital or chromosomal disorders
- neonatal morbidities, or metabolic illness
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 |
|---|---|---|
| β-Palmitate Content | Other | Improved Infant Formula Group |
| Placebo | Other | General Infant Formula Group |
| β-Palmitate Content Naturely in Human Milk | Other | Human Milk Group |
Primary outcome
Content of fatty acids
Time frame: 3 years
Content of calcium and magnesium
Time frame: 3 years
3 secondary outcomes
Anthropometric measurements
Time frame: 3 years
Stool characteristics assessed via stool frequency
Time frame: 3 years
Stool characteristics assessed via stool consistency
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β-Palmitate Content and β-Palmitate Content Naturely in Human Milk in people with Healthy, run by Beingmate Baby & Child Food Co Ltd . 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?
The sponsor lists 1 inclusion and 2 exclusion criteria. 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 2 Nov 2015. 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. Some participants in this study may receive a placebo. 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?
Contact Fei Bei, Master (86-21-38625778, Fionabei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content of fatty acids (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2015.