Phase 2
N=47
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Nutrient Deficiency · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT03750968 ↗Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Jul 2023
Primary outcome: Primary: Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant — 12244; 7343 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carotenoid Group (Drug); Control Group (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Paul S. Bernstein
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant |
12244; 7343 | — |
| PRIMARY Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant |
1030.2; 252.0 | — |
| PRIMARY Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant |
55419; 38475 | — |
| SECONDARY Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density |
0.05; 0.04 | — |
| SECONDARY Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography |
270.5; 54.5 | — |
| SECONDARY Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy |
31656; 23011 | — |
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
Data sourced from ClinicalTrials.gov (NCT03750968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.