Prenatal Study in Healthy Pregnant Women

This study is looking for healthy pregnant women, aged 21-40, who are in their second trimester (14-19 weeks pregnant). The goal is to compare two different prenatal supplements: a Prenatal Capsule (a multivitamin and micronutrient blend with an omega softgel) and a Prenatal Gummy (a commercially available multivitamin with omega-3 DHA and EPA). Researchers want to see if taking one of these supplements daily for 12 weeks affects your iron levels. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design: This interventional study plans to enroll 40 healthy pregnant women. Participants will be assigned to either the Prenatal Capsule or the Prenatal Gummy.
What's involved: You would take your assigned prenatal supplement daily for 12 weeks. Your serum iron levels will be measured at the beginning and end of the 12-week period.
Compensation: Not stated in the trial record.
Follow-up: Your iron levels will be measured at the end of the 12-week intervention.

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Prenatal Study in Healthy Pregnant Women

Recruiting

NAAges 21–40InterventionalSupportive care

Perelel Inc.

~40 participants

Updated 2025-12-18 on ClinicalTrials.gov

What's tested:Prenatal CapsulePrenatal Gummy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from Baseline to end of intervention on iron levels

Measured over 12 weeks

Conditions

Pregnancy

Where it's being run

1 sites across 1 states

Illinois1

Who to contact

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

[email protected]

312-535 -9440

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Eligibility criteria

Inclusion

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

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:

What this trial measures

Change from Baseline to end of intervention on iron levels12 weeks
Serum iron will be measured as primary outcome

Trialytics