Mineral Absorption in the UrineNCT01177917
Evaluation of Mineral Absorption in Infants Fed Infant Formula
A study testing Infant Formula in people with Mineral Absorption in the Urine, run by Mead Johnson Nutrition at 5 sites in United States.
Trial summary
This clinical trial will help determine if prebiotics can increase mineral absorption in babies Read more about this study
- Who is it for?
- Ages 56 to 70 daysHealthy volunteers can take part
- Conditions the study is for
- Mineral Absorption in the Urine
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 5 sitesUnited States
- Study dates
- Aug 2006to Oct 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
- Singleton
- Term infant
- Birth weight of 2500 g or more
- 56-70 days of age
- Signed informed consent
- Consuming a cow's milk-based infant formula for at least 24 hours.
Who cannot join
- History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
- Use of multiple vitamin and mineral supplements prior to enrollment.
- Evidence of formula intolerance or poor intake at time of randomization
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati Children's Hospital Medical Center Clinical Trials Office
Cincinnati, Ohio, 45229
Children's Hospital of Iowa
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
This clinical trial will help determine if prebiotics can increase mineral absorption in babies
- Conditions
- Mineral Absorption in the Urine
- Being tested
- Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| Cow milk-based infant formula with prebiotic blend | Experimental | Not described Receives: Other: Infant Formula |
| Marketed Cow milk-based infant formula | Placebo comparator | Not described Receives: Other: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the amount of minerals in the urine
Secondary outcomes (1)
Compare the amount of vitamins and minerals in the blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mineral Absorption in the UrineStudies 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177917
- Sponsor's protocol ID
- 3371-4
- Status last verified
- Aug 2010
- First submitted
- 6 Aug 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. 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
- NCT01177917
- Acronym / sponsor ID
- 3371-4
- Conditions
- Mineral Absorption in the Urine
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Aug 2010 (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.
This clinical trial will help determine if prebiotics can increase mineral absorption in babies
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow milk-based infant formula with prebiotic blend | Experimental | Other: Infant Formula |
| Marketed Cow milk-based infant formula | Placebo comparator | Other: Infant Formula |
Who may qualify
- Ages
- 56 to 70 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Singleton
- Term infant
- Birth weight of 2500 g or more
- 56-70 days of age
- Signed informed consent
Key exclusion criteria (3 listed)
- History of underlying disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the mineral absorption of the participant
- Use of multiple vitamin and mineral supplements prior to enrollment.
- Evidence of formula intolerance or poor intake at time of randomization
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 | Other | Cow milk-based infant formula with prebiotic blend, Marketed Cow milk-based infant formula |
Primary outcome
To evaluate the amount of minerals in the urine
1 secondary outcome
Compare the amount of vitamins and minerals in the blood
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 9 Aug 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Mineral Absorption in the Urine, 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 6 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 9 Aug 2010. 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. 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?
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?
To evaluate the amount of minerals in the urine. 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 9 Aug 2010.