Prenatal Study in Healthy Pregnant Women

Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: Prenatal Capsule; Dietary supplement: Prenatal Gummy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator; Phone Number: 312-535 -9440; Email: sboetto@atlantiatrials.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Atlantia Clinical Trials, Chicago
      • Contact: Kevin O'Regan Operations Manager; Phone Number: 312-535-9440; Email: koregan@atlantiatrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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, put the Participant at risk, or would confound the interpretation of the study results as judged by the investigator on the basis of medical history.
• Severe nausea and vomiting in the first trimester, including hyperemesis gravidarum (HG)
• Inability to tolerate oral supplement intake due to gastrointestinal symptoms during the first trimester of pregnancy
• Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects))
• Current pregnancy complications (GD, Iron Deficiency Anemia)
• Hypertension
• Diabetes mellitus
• Cardiovascular disease
• Class II/III obesity (defined as BMI ≥35.0 Kg/m2)
• Malabsorption syndromes (e.g., celiac disease, inflammatory bowel disease)
• Severe anemia or iron overload disorders
• Thyroid disorders
• Current or recent (in the past 12 weeks prior to Visit 1) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, as judged by the investigator. Prohibited medications include:

Medications that contain fat-soluble vitamins A, E, or K in high doses

- Current or recent (in the past 12 weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prenatal Capsules; Prenatal serving is 2 capsules + one omega softgel	Dietary supplement: Prenatal 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.; Other Names: Perelel Prenatal
Active Comparator: Gummy Prenatal; Prenatal serving is 2 gummies that also contains omega	Dietary supplement: Prenatal Gummy; This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to end of intervention on iron levels	Serum iron will be measured as primary outcome	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to end of intervention on folate status	Change from baseline (Day 1) to end of intervention in Prenatal capsule compared to Comparator product on red blood cell folate	12 weeks
Change from baseline to end of intervention on omega-3 status	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	12 weeks
Change from baseline to end of intervention on serum Vitamin D	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)	12 weeks
Change from baseline to end of intervention on choline status	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	12 weeks

Collaborators and Investigators

• Sponsor: Perelel Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Estimated): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Maternal Health Services; Prenatal Care
• Other Study ID Numbers: AFCRO-200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No