A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function.

A prospective, randomized, double blind study comparing lutein to placebo for reducing occurrence and severity of retinopathy of prematurity, and evaluating antioxidative power and central visual function. - Lutein supplementation in preterm infants. A RCT.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007041

Enrollment

Registered

2012-01-20

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Preterm infants

Interventions

Administration of oral supplementation of Lutein Administration of oral placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age less than or equal to 34 weeks; ability to tolerate minimal enteral feeding before the seventh day of life; parent consent

Exclusion criteria

Exclusion criteria: Congenital malformations; chromosomal abnormalities

Design outcomes

Primary

Measure	Time frame
Prevalence and severity of retinopathy of prematurity; biological antioxidative power; central visual function.	—

Countries

Europe

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026