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NCT Number: NCT07226414

Prenatal Study 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

Recruiting

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Key information

Conditions

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Clinical Trials, Chicago

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Kevin O'Regan Operations Manager

CONTACT

[email protected]

312-535-9440

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Perelel Prenatal

Prenatal Gummy

Dietary Supplement

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

Primary outcomes

  1. Change from Baseline to end of intervention on iron levels

    Time frame: 12 weeks

    Serum iron will be measured as primary outcome

Secondary outcomes

  1. Change from baseline to end of intervention on folate status

    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

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

    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

  3. Change from baseline to end of intervention on serum Vitamin D

    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)

  4. Change from baseline to end of intervention on choline status

    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

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

312-535 -9440

Sponsors and collaborators

Lead sponsor

Perelel Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Dec 18, 2025

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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