Perelel Prenatal Supplements vs. Generic Prenatal Supplements and Health of Mother and Baby (SUPPORT)

NCT ID: NCT07046845

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-06-30

Brief Summary

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The goal of this clinical trial is to learn if using Perelel-brand prenatal supplements versus a generic prenatal supplement improves the health of the mother and fetus (unborn baby) during pregnancy.

The main question it aims to answer is:

• How does taking Perelel prenatal supplements versus generic prenatal supplements during pregnancy change the nutritional markers in blood samples?

Participants will:

* Take either Perelel or generic prenatal supplements daily throughout pregnancy
* Visit UPMC Magee-Womens Hospital once every trimester of pregnancy for blood draws and answering questionnaires

In an observational part of this study for different participants, researchers will use blood tests and questionnaires only once during the first trimester to compare pregnant women without food insecurity to those with food insecurity.

Detailed Description

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Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Perelel Prenatal Supplement Group

Group Type ACTIVE_COMPARATOR

Perelel Prenatal Vitamin

Intervention Type DIETARY_SUPPLEMENT

Daily Perelel prenatal vitamin supplement throughout pregnancy

Generic Prenatal Supplement Group

Group Type ACTIVE_COMPARATOR

Generic Prenatal Vitamin

Intervention Type DIETARY_SUPPLEMENT

Daily generic prenatal vitamin supplement throughout pregnancy.

Observational Arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Perelel Prenatal Vitamin

Daily Perelel prenatal vitamin supplement throughout pregnancy

Intervention Type DIETARY_SUPPLEMENT

Generic Prenatal Vitamin

Daily generic prenatal vitamin supplement throughout pregnancy.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Pregnant with only one baby
2. Identify as having food insecurity
3. Receiving care at a Magee-Womens Hospital associated prenatal practice
4. Less than 12 weeks' of pregnancy

Exclusion Criteria

1. Currently using prenatal supplement(s)
2. Unborn baby (fetus) identified as having a chromosomal or structural defect
3. Have a condition that prevents absorption of nutrients from food
4. History of medically treated thyroid disorder
5. Ongoing steroid use
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Perelel Inc.

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Hyagriv Simhan

Professor & Executive Vice Chair, OB/GYN/RS, Director, Clinical Innovation in Women's Health, UPMC

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyagriv Simhan, MD

Role: PRINCIPAL_INVESTIGATOR

Magee-Women's Research Institute

Locations

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UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeanette Boyce, RNC, MSN

Role: CONTACT

412-641-4072

Facility Contacts

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Jeanette Boyce Boyce

Role: primary

412-641-4072

Other Identifiers

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STUDY25020013

Identifier Type: -

Identifier Source: org_study_id

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