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Dietary Lutein and the Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT00672230
Recruitment Status : Unknown
Verified May 2008 by Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : May 6, 2008
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:

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
Lactation Dietary Supplement: 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : August 2005
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein
U.S. FDA Resources

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 [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Plasma Lutein, mcg/dL [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672230


Contacts
Contact: Sonja L Connor, MS 503-494-7775 connors@ohsu.edu
Contact: William E Connor, MD 503-494-2001 connorw@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Sonja L Connor, MS    503-494-7775    connors@ohsu.edu   
Contact: William E Connor, MD    503-494-2001    connorw@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: William E Connor, MD Oregon Health and Science University
More Information

Responsible Party: William E. Connor, MD, Professor; Endocrinology, Metabolism and Clinical Nutrition, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00672230     History of Changes
Other Study ID Numbers: OHSUeirb00000403
USDA 2005-35200-16165
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008

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

Additional relevant MeSH terms:
Retinopathy of Prematurity
Retinal Diseases
Eye Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases