InfantPhase 4NCT00941564
Comparative Ca Absorption and Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends
A Phase 4 study testing Infant Formula milk based in people with Infant, run by Abbott Nutrition at 1 site in Brazil.
Trial summary
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends. Read more about this study
- Who is it for?
- Ages 84 to 159 daysHealthy volunteers can take part
- Conditions the study is for
- Infant
- What is being tested?
- Infant Formula milk based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to May 2010
- Phase
- Phase 4
- 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 84 to 159 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
- Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.
Who cannot join
- Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics 3 days prior to enrollment.
- Infant has received probiotics-containing products 3 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Pediatrics, Federal University of Bahia
Salvador, Estado de Bahia
About this study
Official title: "Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
The objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.
- Conditions
- Infant
- Being tested
- Infant Formula milk based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula milk basedOther
Consume ad lib
Infant formula milk basedOther
consume ad lib
| Study group | Role | What they receive |
|---|---|---|
| Commercially available infant formula A | Experimental | Varying fat blend from comparator product Receives: Other: Infant Formula milk based |
| Commercially available infant formula B | Active comparator | Not described Receives: Other: Infant formula milk based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium absorption
Measured: 18 days
Secondary outcomes (1)
Calcium retention, fat absorption, tolerance
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfantStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Lasekan, PhD, Study director, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941564
- Sponsor's protocol ID
- AK76
- Status last verified
- Nov 2010
- First submitted
- 14 Jul 2009
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Souza CO, Leite MEQ, Lasekan J, Baggs G, Pinho LS, Druzian JI, Ribeiro TCM, Mattos AP, Menezes-Filho JA, Costa-Ribeiro H. Milk protein-based formulas containing different oils affect fatty acids balance in term infants: A randomized blinded crossover clinical trial. Lipids Health Dis. 2017 Apr 14;16(1):78. doi: 10.1186/s12944-017-0457-y.
PubMed 28410612Leite ME, Lasekan J, Baggs G, Ribeiro T, Menezes-Filho J, Pontes M, Druzian J, Barreto DL, de Souza CO, Mattos A, Costa-Ribeiro H Jr. Calcium and fat metabolic balance, and gastrointestinal tolerance in term infants fed milk-based formulas with and without palm olein and palm kernel oils: a randomized blinded crossover study. BMC Pediatr. 2013 Dec 24;13:215. doi: 10.1186/1471-2431-13-215.
PubMed 24367946
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparative Calcium Absorption and Gastrointestinal Tolerance in Healthy Term Infants Fed Milk-based Formulas With Different Fat Blends"
- ClinicalTrials.gov ID
- NCT00941564
- Acronym / sponsor ID
- AK76
- Conditions
- Infant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Jul 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 objective is to assess the comparative calcium absorption and gastrointestinal (GI) tolerance in healthy normal term infants fed two commercially available powdered milk-based formulas which contain different fat blends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Commercially available infant formula A | Experimental | Other: Infant Formula milk basedVarying fat blend from comparator product |
| Commercially available infant formula B | Active comparator | Other: Infant formula milk based |
Who may qualify
- Ages
- 84 to 159 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infant in good health, full term, singleton birth and 84-156 days of age at enrollment. Male infants only to be enrolled for primary variable measures.
- Restrict use of certain medications or home remedies, herbal preparations, probiotics or rehydration/intravenous (IV) fluids.
Key exclusion criteria (3 listed)
- Adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics 3 days prior to enrollment.
- Infant has received probiotics-containing products 3 days prior to enrollment.
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 milk basedConsume ad lib | Other | Commercially available infant formula A |
| Infant formula milk basedconsume ad lib | Other | Commercially available infant formula B |
Primary outcome
Calcium absorption
Time frame: 18 days
1 secondary outcome
Calcium retention, fat absorption, tolerance
Time frame: 18 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
- Derived from this study: PubMed 28410612Souza CO, Leite MEQ, Lasekan J, Baggs G, Pinho LS, Druzian JI, Ribeiro TCM, Mattos AP, Menezes-Filho JA, Costa-Ribeiro H. Milk protein-based formulas containing different oils affect fatty acids balance in term infants: A randomized blinded crossover clinical trial. Lipids Health Dis. 2017 Apr 14;16(1):78. doi: 10.1186/s12944-017-0457-y.
- Derived from this study: PubMed 24367946Leite ME, Lasekan J, Baggs G, Ribeiro T, Menezes-Filho J, Pontes M, Druzian J, Barreto DL, de Souza CO, Mattos A, Costa-Ribeiro H Jr. Calcium and fat metabolic balance, and gastrointestinal tolerance in term infants fed milk-based formulas with and without palm olein and palm kernel oils: a randomized blinded crossover study. BMC Pediatr. 2013 Dec 24;13:215. doi: 10.1186/1471-2431-13-215.
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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.
John Lasekan, PhD study director
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infant Formula milk based in people with Infant, run by Abbott Nutrition at 1 site in Brazil.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 25 Nov 2010. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Calcium absorption (time frame: 18 days). 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 NCT00941564, which also lists 2 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 25 Nov 2010.