Dietary Lutein and the Retinopathy of Prematurity

Lactation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672230
• Other study ID #: OHSUeirb00000403
• Secondary ID: USDA 2005-35200-
• Status: Completed
• Phase: N/A
• Start date: August 2005
• Est. completion date: July 2009

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: July 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lactation

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk lutein, mcg/dL		4 weeks
Secondary	Plasma Lutein, mcg/dL		4 weeks