Prenatal Study in Healthy Pregnant Women

NCT07226414 | Recruiting

• 1 other identifier: AFCRO-200
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline to end of intervention on iron levels

  Serum iron will be measured as primary outcome

  12 weeks

Secondary Outcomes (4)

• Change from baseline to end of intervention on folate status

  12 weeks

• Change from baseline to end of intervention on omega-3 status

  12 weeks

• Change from baseline to end of intervention on serum Vitamin D

  12 weeks

• Change from baseline to end of intervention on choline status

  12 weeks

Study Arms (2)

Prenatal Capsules

EXPERIMENTAL

Prenatal serving is 2 capsules + one omega softgel

Dietary Supplement: Prenatal Capsule

Gummy Prenatal

ACTIVE COMPARATOR

Prenatal serving is 2 gummies that also contains omega

Dietary Supplement: Prenatal Gummy

Interventions

Prenatal Capsule DIETARY_SUPPLEMENT

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.

Also known as: Perelel Prenatal

Prenatal Capsules

Prenatal Gummy DIETARY_SUPPLEMENT

This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA

Gummy Prenatal

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Requires biological females (pregnancy)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Perelel Inc.: lead

Study Sites (1)

Atlantia Clinical Trials, Chicago

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Prenatal Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator

CONTACT

312-535 -9440; sboetto@atlantiatrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

US (1)