Status:
COMPLETED
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Lead Sponsor:
Paul S. Bernstein
Conditions:
Nutrient Deficiency
Pregnancy Related
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligram...
Eligibility Criteria
Inclusion
- Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated obstetric history and plan to deliver either vaginally or by Caesarian section at the University of Utah for their current pregnancy.
Exclusion
- Women who have regularly taken carotenoid supplements containing more than 0.5 mg of lutein and/or zeaxanthin daily during the six months prior to screening
- Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).
- Women with conditions associated with high-risk pregnancy such as adolescent pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia, previous premature delivery, drug abuse or other significant medical illness
Key Trial Info
Start Date :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03750968
Start Date
September 26 2019
End Date
January 31 2022
Last Update
July 11 2023
Active Locations (1)
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1
University of Utah John A. Moran Eye Center
Salt Lake City, Utah, United States, 84132