Dietary Lutein and the Retinopathy of Prematurity

Study Overview
=================
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.

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).

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

Conditions
-----------------
Lactation

Intervention / Treatment
-----------------
* Dietary Supplement: Lutein supplement


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lut Supp<br> | Dietary Supplement: Lutein supplement<br>* Subjects will be randomized to take a lutein supplement(12mg/day) lactation weeks 5-8 or to not take a lutein supplement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk lutein, mcg/dL |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Lutein, mcg/dL |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactation, Breast milk, Lutein, Lutein supplement