Actively Recruiting
Prenatal Study in Healthy Pregnant Women
Led by Perelel Inc. · Updated on 2025-12-18
40
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Prenatal Study in Healthy Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent
- Healthy pregnant women between 21 and 40 years of age (inclusive)
- Pregnant women in the second trimester with gestational age of 14 to 19 weeks
- Willing to consume the study product daily for the duration of the study
You will not qualify if you...
- History of drug or alcohol abuse
- Hypersensitivity to any contents of the study products
- Significant acute or chronic health conditions that prevent study participation or pose risk
- Severe nausea and vomiting in first trimester, including hyperemesis gravidarum
- Inability to tolerate oral supplements due to gastrointestinal symptoms in first trimester
- Prior pregnancy complications such as gestational diabetes, hyperemesis gravidarum, pre-eclampsia, or neural tube defects
- Current pregnancy complications including gestational diabetes or iron deficiency anemia
- Hypertension
- Diabetes mellitus
- Cardiovascular disease
- Class II/III obesity (BMI ≥35.0 Kg/m2)
- Malabsorption syndromes like celiac disease or inflammatory bowel disease
- Severe anemia or iron overload disorders
- Thyroid disorders
- Current or recent (past 12 weeks) use of medications or supplements that interfere with study objectives or safety, including high doses of fat-soluble vitamins A, E, or K
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Trial Site Locations
Total: 1 location
1
Atlantia Clinical Trials, Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
D
Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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