Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
Perelel Inc.
Summary
Clinical Trial Summary The goal of this clinical trial is to address the impact of a gummy prenatal vs a capsule based prenatal in pregnant women. The main question it aims to answer is: Does 12-week daily administration of Prenatal Capsule affect serum iron levels in pregnant women in their second trimester compared to a comparator gummy prenatal? Researchers will compare Prenatal Capsule to a comparator Prenatal Gummy to see if there are differences in serum iron levels after 12 weeks of daily use. Participants will: Take their assigned prenatal supplement (either Prenatal Capsule or the comparator Prenatal Gummy) daily for 12 weeks Be in their second trimester of pregnancy during the study period Have their serum iron levels measured at baseline and after the 12-week intervention period
Eligibility
- Age range
- 21–40 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Be able to give written informed consent. * Healthy pregnant women between 21- 40 years of age (inclusive). * Pregnant women in the second trimester of pregnancy (gestational age of 14-19 weeks). * Willing to consume the Study Product daily for the duration of the study. Exclusion Criteria: * History of drug or alcohol abuse * Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products. * Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, p…
Interventions
- Dietary SupplementPrenatal Capsule
This study will look at the impacts of a prenatal capsule vs a gummy comparator prenatal. The prenatal consists of 2 multivitamin + micronutrient blend with one omega softgel.
- Dietary SupplementPrenatal Gummy
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
Location
- Atlantia Clinical Trials, ChicagoChicago, Illinois