Recruiting

Perelel Prenatal

Sponsor:

University of Pittsburgh

Code:

NCT07046845

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Perelel Prenatal Vitamin

Generic Prenatal Vitamin

Study Details

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.

Conditions

Pregnancy

Study ID

NCT07046845

Start date

Jan 7, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Perelel Prenatal Supplement Group

active comparator: Generic Prenatal Supplement Group

no intervention: Observational Arm

Interventions

Perelel Prenatal Vitamin

Daily Perelel prenatal vitamin supplement throughout pregnancy

Generic Prenatal Vitamin

Daily generic prenatal vitamin supplement throughout pregnancy.

Primary outcome measure

  • Marker of Maternal Vitamin D Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Total Folate (RBC) Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Total Folate (Serum) Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Serum Ferritin Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Serum Vitamin B12 Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Homocysteine Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]
  • Marker of Maternal Folate Metabolites Nutritional Status [ Time Frame: Through study completion, an average of 30 weeks ]

Central Contacts and Locations

Central contacts

Jeanette Boyce, RNC, MSN

412-641-4072tessje@upmc.edu

Locations

UPMC Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jeanette Boyce Boyce

412-641-4072tessje@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-02-04.