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| Sponsor: | Oregon Health and Science University |
|---|---|
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00672230 |
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 |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Sonja L Connor, MS | 503-494-7775 | connors@ohsu.edu |
| Contact: William E Connor, MD | 503-494-2001 | connorw@ohsu.edu |
| 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 | |
| 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 |
| Study First Received: | May 2, 2008 |
| Last Updated: | May 5, 2008 |
| Health Authority: | United States: Institutional Review Board |
|
Lactation Breast milk Lutein Lutein supplement |
|
Retinopathy of Prematurity Retinal Diseases Eye Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |
