Status:
COMPLETED
Maternal Carotenoids Across Pregnancy Study
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
United States Department of Agriculture (USDA)
Conditions:
Healthy Nutrition
Pregnancy Related
Eligibility:
FEMALE
18-40 years
Brief Summary
Before infants are born, they depend on their mother to provide the nutrients necessary to grow and develop, such as iron, folic acid, iodine and other vitamins and minerals. Pregnant people also rely...
Detailed Description
What a pregnant person eats is important for their own health and the health of their infant during pregnancy and after birth. Fruits and vegetables contain colorful substances called "carotenoids" wh...
Eligibility Criteria
Inclusion
- Pregnant group
- a pregnancy confirmed by positive pregnancy test and/or ultrasound
- pre-pregnancy BMI 18.5-29.9 kg/m\^2
- can speak, read, and understand English
- agrees to take the prescribed daily prenatal multivitamin as recommended by their licensed prenatal healthcare provider throughout the study.
- Non-pregnant group
- current BMI that is lean 18.5-29.9 kg/m\^
- can speak, read, and understand English
- agrees to continue taking any daily multivitamins or supplements throughout the study
- consumes alcohol moderately as outlined by current guidelines.
- Infants
- born at term (37 weeks gestation or more)
- if infant was one of multiple births, only one sibling may be enrolled.
Exclusion
- Metabolic, kidney, liver, digestive, or malabsorptive disorders with special dietary recommendations for the adult female or infant
- currently uses tobacco, or drugs; consumes alcohol beyond current recommendations (zero in pregnancy, 1 drink daily average for non-pregnant)
- adult female currently taking any isolated carotenoid supplements or high carotenoid (\>2 mg/d) supplements
- adult female currently consumes an exclusively vegan or vegetarian diet
- adult female uses medications that interfere with dietary fat absorption
- adult female has history of endocrine disorders requiring hormone administration (with the exception of medically managed hypothyroidism).
- pregnant adult female has been informed by her doctor that she will need to take hormones during her pregnancy
- adult female has current vision condition or disease that prevents them from seeing clearly regardless of corrective lenses.
- adult female is currently lactating at enrollment.
Key Trial Info
Start Date :
September 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06004479
Start Date
September 14 2022
End Date
December 12 2024
Last Update
December 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas, United States, 77030