NCT07046845

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
14mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

March 5, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

March 5, 2025

Last Update Submit

February 2, 2026

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (7)

  • Marker of Maternal Vitamin D Nutritional Status

    Assay of Serum 25-hydroxyvitamin D3 in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Total Folate (RBC) Nutritional Status

    Assay of Total Folate (RBC) in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Total Folate (Serum) Nutritional Status

    Assay of Total Folate (Serum) in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Serum Ferritin Nutritional Status

    Assay of Serum Ferritin in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Serum Vitamin B12 Nutritional Status

    Assay of Serum Vitamin B12 in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Homocysteine Nutritional Status

    Assay of Homocysteine in Blood Samples

    Through study completion, an average of 30 weeks

  • Marker of Maternal Folate Metabolites Nutritional Status

    Assay of Folate Metabolites in Blood Samples

    Through study completion, an average of 30 weeks

Secondary Outcomes (9)

  • Symptoms of Nausea and Vomiting in Pregnancy

    Through study completion, an average of 30 weeks

  • Symptoms of Depression in Pregnancy

    Through study completion, an average of 30 weeks

  • Symptoms of Anxiety in Pregnancy

    Through study completion, an average of 30 weeks

  • Symptoms of Stress in Pregnancy

    Through study completion, an average of 30 weeks

  • Sleep Quality in Pregnancy

    Through study completion, an average of 30 weeks

  • +4 more secondary outcomes

Study Arms (3)

Perelel Prenatal Supplement Group

ACTIVE COMPARATOR
Dietary Supplement: Perelel Prenatal Vitamin

Generic Prenatal Supplement Group

ACTIVE COMPARATOR
Dietary Supplement: Generic Prenatal Vitamin

Observational Arm

NO INTERVENTION

Interventions

Generic Prenatal VitaminDIETARY_SUPPLEMENT

Daily generic prenatal vitamin supplement throughout pregnancy.

Generic Prenatal Supplement Group
Perelel Prenatal VitaminDIETARY_SUPPLEMENT

Daily Perelel prenatal vitamin supplement throughout pregnancy

Perelel Prenatal Supplement Group

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Currently using prenatal supplement(s)
  • Unborn baby (fetus) identified as having a chromosomal or structural defect
  • Have a condition that prevents absorption of nutrients from food
  • History of medically treated thyroid disorder
  • Ongoing steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Study Officials

  • Hyagriv Simhan, MD

    Magee-Women's Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Boyce, RNC, MSN

CONTACT

412-641-4072tessje@upmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Executive Vice Chair, OB/GYN/RS, Director, Clinical Innovation in Women's Health, UPMC

Study Record Dates

First Submitted

March 5, 2025

First Posted

July 2, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)