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

University of Pittsburgh

Status: Begins enrollment in 1 month

Conditions: Pregnancy

Treatments: Dietary Supplement: Perelel Prenatal Vitamin; Dietary Supplement: Generic Prenatal Vitamin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07046845

STUDY25020013

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Perelel Prenatal Supplement Group

Active Comparator group

Treatment:

Dietary Supplement: Perelel Prenatal Vitamin

Generic Prenatal Supplement Group

Active Comparator group

Treatment:

Dietary Supplement: Generic Prenatal Vitamin

Observational Arm

No Intervention group