Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Carotenoid group
The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.
干预措施: Carotenoid Group (Drug)
Control group
The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.
干预措施: Control Group (Dietary Supplement)
结局指标
主要结局
Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant
时间窗: up to 13 weeks gestation to birth
measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant
时间窗: up to 13 weeks gestation to birth
Maternal skin carotenoid levels are measured in Raman units.
Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant
时间窗: up to 13 weeks gestation to birth
We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2
次要结局
- Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density(Birth)
- Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography(Birth)
- Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy(Birth)
研究者
Paul S. Bernstein
Professor, Ophthalmology/Visual Sciences
University of Utah