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Dietary Lutein and the Retinopathy of Prematurity

The Placental and Mammary Transfer of Lutein and Zeaxanthin Into the Fetus and the Breast-fed Infant

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00672230
Enrollment
212
Registered
2008-05-06
Start date
2005-08-31
Completion date
2009-07-31
Last updated
2019-08-28

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

Conditions

Lactation

Keywords

Lactation, Breast milk, Lutein, Lutein supplement

Brief summary

The clinical trial aspect of this study is the provision of a lutein supplement to lactating women and compare the amount of lutein in the milk and blood with lactating women who do not receive the lutein supplement.

Detailed description

About one-fourth of preterm infants who weight less than 2 3/4 pounds at birth develop an eye problem. This problem occurs in the retina (back of the eye) and may result in blindness. This eye problem is called the retinopathy of prematurity(ROP). There are two yellow pigments in the retina called lutein and zeaxanthin. These pigments may protect the retina from being damaged by light. They may also protect the retina from being damaged by oxygen. These pigments are transferred from the mother to the baby. Most of this takes place during the last trimester of pregnancy. The situation could be worse if the baby receives formula. Most baby formulas do not contain lutein and zeaxanthin; breast milk does. Another worry is that breast milk may not have enough lutein and zeaxanthin if the mother does not eat enough vegetables and fruits. The purpose of this study is to measure the transfer of lutein and zeaxanthin from the mother to the baby, to measure the amount of lutein and zeaxanthin in breast milk, to find out if taking a lutein supplement will increase the amount of lutein in breast milk and to find out if dietary lutein and zeaxanthin are involved in the development of the retinopathy of prematurity (ROP).

Interventions

DIETARY_SUPPLEMENTLutein supplement

Subjects will be randomized to take a lutein supplement(12mg/day) lactation weeks 5-8 or to not take a lutein supplement

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Planning to breast feed for at least 12 weeks * Willing to be randomized to take the lutein supplement

Exclusion criteria

* Insufficient quantity of breast milk

Design outcomes

Primary

MeasureTime frame
Breast milk lutein, mcg/dL4 weeks

Secondary

MeasureTime frame
Plasma Lutein, mcg/dL4 weeks

Countries

United States

Outcome results

None listed

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