Prenatal Study in Healthy Pregnant Women

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Perelel Inc.
Study ID
NCT07226414
Status
Recruiting

Conditions

  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 40 Years
Healthy Volunteers
Not accepted

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.
  • Prenatal Gummy — DIETARY_SUPPLEMENT
    This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA

Study Details

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

Key Dates

Start date
Dec 1, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prenatal Capsules
    Prenatal serving is 2 capsules + one omega softgel
  • Active Comparator: Gummy Prenatal
    Prenatal serving is 2 gummies that also contains omega

Primary Outcome Measure

Change from Baseline to end of intervention on iron levels [ Time Frame: 12 weeks ]

Central Contacts

  • Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
    312-535 -9440

Locations (1)

FacilityCityStateZIPSite coordinators
Atlantia Clinical Trials, ChicagoChicagoIllinois60611
Kevin O'Regan Operations Manager
312-535-9440

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