Clinical trial NCT03750968: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Official title: Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nutrient Deficiency
Pregnancy Related
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure.

Mothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
timeFrame: up to 13 weeks gestation to birth
measure: Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant
timeFrame: up to 13 weeks gestation to birth
measure: Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant
timeFrame: up to 13 weeks gestation to birth
Secondary outcomes:
measure: Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density
timeFrame: Birth
measure: Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography
timeFrame: Birth
measure: Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy
timeFrame: Birth
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah John A. Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah Moran Eye Center
name: Paul S Bernstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Addo EK, Gorusupudi A, Allman S, Bernstein PS. The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study-carotenoid supplementation during pregnancy: ocular and systemic effects-study protocol for a randomized controlled trial. Trials. 2021 Apr 22;22(1):300. doi: 10.1186/s13063-021-05244-2.