Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | April 1, 2019 |
| End Date: | December 31, 2022 |
| Contact: | Paul S Bernstein, MD, PhD |
| Email: | Paul.Bernstein@hsc.utah.edu |
| Phone: | 801-581-4069 |
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 6.0 milligrams of lutein and 0.5 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.
period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation
with 6.0 milligrams of lutein and 0.5 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.
Inclusion Criteria:
- Pregnant multi-gravid women with uncomplicated obstetric histories
- Women planning to deliver their baby at the University of Utah
- Women planning either vaginal or Caesarian section delivery
Exclusion Criteria:
- Women who have not had previous full-term pregnancy(ies)
- 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
We found this trial at
1
site
Click here to add this to my saved trials
