Dietary Lutein and the Retinopathy of Prematurity

Not Applicable

Completed

• Conditions: Lactation
• Interventions: Dietary Supplement: Lutein supplement

• Registration Number: NCT00672230
• Lead Sponsor: Oregon Health and Science University

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).

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Primary Completion: 2008-09
• Study Completion: 2009-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lut Supp	Lutein supplement	-

Primary Outcome Measures

Name	Time	Method
Breast milk lutein, mcg/dL	4 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma Lutein, mcg/dL	4 weeks

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States