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Dietary Lutein and the Retinopathy of Prematurity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00672230
First received: May 2, 2008
Last updated: May 5, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention
Lactation
 Dietary Supplement: Lutein supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Breast milk lutein, mcg/dL [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Lutein, mcg/dL [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2005
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 2, 2008
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013