Prenatal Study in Healthy Pregnant Women

Perelel Inc.

Status: Enrolling

Conditions: Pregnancy

Treatments: Dietary Supplement: Prenatal Capsule; Dietary Supplement: Prenatal Gummy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07226414

AFCRO-200

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Prenatal Capsules

Experimental group

Description:

Prenatal serving is 2 capsules + one omega softgel

Treatment:

Dietary Supplement: Prenatal Capsule

Gummy Prenatal

Active Comparator group

Description:

Prenatal serving is 2 gummies that also contains omega

Treatment:

Dietary Supplement: Prenatal Gummy