Dietary Lutein and the Retinopathy of Prematurity

• Sponsor: Oregon Health and Science University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00672230
• Collaborator: (none)
• Enrollment: 212
• Location: 1
• Arm: 1
• Duration (Months): 47
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lactation	Dietary Supplement: Lutein supplement	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 212 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Placental and Mammary Transfer of Lutein and Zeaxanthin Into the Fetus and the Breast-fed Infant
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lut Supp	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

Outcome Measures

Primary Outcome Measures

1. Breast milk lutein, mcg/dL [4 weeks]

Secondary Outcome Measures

1. Plasma Lutein, mcg/dL [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239-3098

Sponsors and Collaborators

• Oregon Health and Science University

Investigators

• Principal Investigator: William E Connor, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT00672230
• Other Study ID Numbers: OHSUeirb00000403; USDA 2005-35200-16165
• First Posted: May 6, 2008
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Oregon Health and Science University: Lactation; Breast milk; Lutein; Lutein supplement

Study Results

No Results Posted as of Aug 28, 2019