Atlantia Clinical Trials, Chicago
Chicago, Illinois, 60611, United States
Location status: Recruiting
NCT Number: NCT07226414
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
Interested in participating?
Request Info21 year–40 year
Female
Interventional
Not applicable
Chicago, Illinois, 60611, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Medications that contain fat-soluble vitamins A, E, or K in high doses
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.
Other names: Perelel Prenatal
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
Time frame: 12 weeks
Serum iron will be measured as primary outcome
Time frame: 12 weeks
Change from baseline (Day 1) to end of intervention in Prenatal capsule compared to Comparator product on red blood cell folate
Time frame: 12 weeks
Change from baseline (Day 1) to end of intervention (Day 85) in Prenatal capsule compared to Comparator product on:
Red Blood Cell (RBC) Omega-3 Index (% Total Omega-3 Fatty Acids) Docosahexaenoic acid (DHA) as a percentage of RBC omega-3 fatty acids Eicosapentaenoic acid (EPA) as a percentage of RBC omega-3 fatty acids
Time frame: 12 weeks
Change from baseline (Day 1) to end of intervention (week 12) in Prenatal capsule compared to Comparator product on Serum Vitamin D (25-hydroxyvitamin D (25(OH)D)
Time frame: 12 weeks
Change from baseline (Day 1) to end of intervention (Day 85) in Prenatal capsule compared to Comparator product on: Plasma choline, Plasma betaine, and Plasma zinc
Contact information is provided by the study sponsor or research team.
Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
CONTACT
Perelel Inc.
Industry
Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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