NCT03750968

Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Paul S. Bernstein · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nutrient Deficiency
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Carotenoid Group	Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil
DIETARY_SUPPLEMENT	Control Group	Placebo ingredients: Safflower oil

Timeline

• Start date: 2019-09-26
• Primary completion: 2022-01-31
• Completion: 2022-01-31
• First posted: 2018-11-23
• Last updated: 2023-07-11
• Results posted: 2023-07-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study