Effect of Lutein in S-26 Gold On Growth And Safety

Effect of Lutein in S-26 Gold on Growth and Safety

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00913406

Acronym

S-26 Gold L

Enrollment

232

Registered

2009-06-04

Start date

2005-11-30

Completion date

2006-05-31

Last updated

2009-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Effect of lutein fortification growth healthy term infants

Brief summary

Study to determine if the addition of lutein to infant formula supports healthy growth and development in healthy full term infants.

Interventions

OTHERLutein fortification

OTHERStandard formula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants aged 0-14 days * Full Term birth and AGA Parent(s) signed informed consent

Exclusion criteria

* Unhealthy infant * Participation in other clinical trial * Use of prohibited medications

Design outcomes

Primary

Measure	Time frame
Weight gain/day in grams/day	4 months

Secondary

Measure	Time frame
Collection of adverse experiences	4 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026