HealthyS-26 Gold LNCT00913406
Effect of Lutein in S-26 Gold On Growth And Safety
A study testing Lutein fortification and Standard formula in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lutein fortification and Standard formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- No sites listed yet
- Study dates
- Nov 2005to May 2006
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged 0-14 days
- Full Term birth and AGA Parent(s) signed informed consent
Who cannot join
- Unhealthy infant
- Participation in other clinical trial
- Use of prohibited medications
About this study
Official title: Effect of Lutein in S-26 Gold on Growth and Safety
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.
- Conditions
- Healthy
- Being tested
- Lutein fortification, Standard formula
- Keywords
- Effect of lutein fortification growth healthy term infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein fortificationOther
Standard formulaOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental=Standard formula with lutein added to the formula Receives: Other: Lutein fortification |
| 2 | Active comparator | Active Comparator=Standard formula Receives: Other: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain/day in grams/day
Measured: 4 months
Secondary outcomes (1)
Collection of adverse experiences
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startNov 2005
- Primary completionMay 2006
- Study completionMay 2006
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913406
- Sponsor's protocol ID
- 9041A1-902
- Acronym
- S-26 Gold L
- Status last verified
- Jun 2009
- First submitted
- 28 May 2009
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lutein in S-26 Gold on Growth and Safety
- ClinicalTrials.gov ID
- NCT00913406
- Acronym / sponsor ID
- S-26 Gold L / 9041A1-902
- Conditions
- Healthy
- Keywords
- Effect of lutein fortification growth healthy term infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 4 Jun 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.
Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Lutein fortificationExperimental=Standard formula with lutein added to the formula |
| 2 | Active comparator | Other: Standard formulaActive Comparator=Standard formula |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy infants aged 0-14 days
- Full Term birth and AGA Parent(s) signed informed consent
Key exclusion criteria (3 listed)
- Unhealthy infant
- Participation in other clinical trial
- Use of prohibited medications
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 |
|---|---|---|
| Lutein fortification | Other | 1 |
| Standard formula | Other | 2 |
Primary outcome
Weight gain/day in grams/day
Time frame: 4 months
1 secondary outcome
Collection of adverse experiences
Time frame: 4 months
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 4 Jun 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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A study testing Lutein fortification and Standard formula in people with Healthy, run by Wyeth is now a wholly owned subsidiary of Pfizer.
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 4 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Weight gain/day in grams/day (time frame: 4 months). 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 4 Jun 2009.