NCT00672230

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.1 years

First QC Date

May 2, 2008

Last Update Submit

August 23, 2019

Conditions

Lactation

Keywords

LactationBreast milkLuteinLutein supplement

Outcome Measures

Primary Outcomes (1)

  • Breast milk lutein, mcg/dL

    4 weeks

Secondary Outcomes (1)

  • Plasma Lutein, mcg/dL

    4 weeks

Study Arms (1)

Lut Supp

EXPERIMENTAL
Dietary Supplement: Lutein supplement

Interventions

Lutein supplementDIETARY_SUPPLEMENT

Subjects will be randomized to take a lutein supplement(12mg/day) lactation weeks 5-8 or to not take a lutein supplement

Lut Supp

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planning to breast feed for at least 12 weeks
  • Willing to be randomized to take the lutein supplement

You may not qualify if:

  • Insufficient quantity of breast milk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • William E Connor, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

August 1, 2005

Primary Completion

September 1, 2008

Study Completion

July 1, 2009

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

US(1)