HealthyNCT00366873
Evaluation of Mineral Absorption in Infants Fed Infant Formula
A study testing Calcium absorption in people with Healthy, run by Mead Johnson Nutrition at 5 sites in United States.
Trial summary
The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics. Read more about this study
- Who is it for?
- Ages 56 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Calcium absorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2006to Dec 2008
- 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 56 to 70 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, term infants
Who cannot join
- Breast fed infants
- Use of vitamin/mineral supplements
- Currently on medication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Fomon Infant Nutrition Unit
Coralville, Iowa, 52241
Children's Research and Nutrition Center
Houston, Texas, 77030
Pediatric Clinical Trials Unit
Louisville, Kentucky, 40202
The Center for Human Nutrition
Omaha, Nebraska, 68105
About this study
The purpose of this study is to measure calcium absorption in infants fed formula with and without prebiotics.
Read the detailed description
Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.
- Conditions
- Healthy
- Being tested
- Calcium absorption
- Keywords
- Infant, Term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium absorptionProcedure or surgery
formula with or without prebiotics
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cow-milk based infant formula Receives: Procedure: Calcium absorption |
| 2 | Experimental | cow-milk based infant formula with prebiotics Receives: Procedure: Calcium absorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium absorption
Measured: 14 days
Secondary outcomes (1)
Vitamin D levels
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2008
- Study completionDec 2008
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Heubi, M.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366873
- Sponsor's protocol ID
- 3374-1151
- Status last verified
- Mar 2009
- First submitted
- 17 Aug 2006
- Last updated
- 5 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mineral Absorption in Infants Fed Infant Formula
- ClinicalTrials.gov ID
- NCT00366873
- Acronym / sponsor ID
- 3374-1151
- Conditions
- Healthy
- Keywords
- Infant, Term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Aug 2006 (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 measure calcium absorption in infants fed formula with and without prebiotics.
Detailed description
Infants will be fed formula and blood drawn and urine collected to measure calcium absorption.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Calcium absorptioncow-milk based infant formula |
| 2 | Experimental | Procedure: Calcium absorptioncow-milk based infant formula with prebiotics |
Who may qualify
- Ages
- 56 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy, term infants
Key exclusion criteria (3 listed)
- Breast fed infants
- Use of vitamin/mineral supplements
- Currently on medication
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 |
|---|---|---|
| Calcium absorptionformula with or without prebiotics | Procedure or surgery | 1, 2 |
Primary outcome
Calcium absorption
Time frame: 14 days
1 secondary outcome
Vitamin D levels
Time frame: 14 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 5 Mar 2009.
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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.
James Heubi, M.D. principal investigator
Children's Hospital Medical Center, Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium absorption in people with Healthy, run by Mead Johnson Nutrition at 5 sites in United States.
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 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 5 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
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: 14 days). 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 5 Mar 2009.