Perelel versus generic prenatal vitamins for mother and baby health
Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial
This test will see if taking Perelel prenatal vitamins instead of a generic prenatal vitamin during pregnancy changes blood nutrient levels for pregnant people with food insecurity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07046845 on ClinicalTrials.gov |
What this trial studies
Pregnant participants under 12 weeks with a single fetus who identify as food insecure and receive care at Magee-Womens Hospital will be enrolled and asked to take either Perelel or a generic prenatal supplement daily through pregnancy. Participants will come to UPMC Magee-Womens Hospital once each trimester for blood draws and questionnaires to measure nutritional markers, and a separate observational group will have a one-time first-trimester blood test and questionnaire to compare those with and without food insecurity. Key exclusions include current prenatal supplement use, known fetal chromosomal or structural defects, conditions that prevent nutrient absorption, medically treated thyroid disorder, or ongoing steroid use. The study measures changes in blood nutritional markers rather than clinical pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant people under 12 weeks with a single fetus who identify as food insecure, receive prenatal care at a Magee-Womens Hospital practice, and are not currently taking prenatal supplements.
Not a fit: People already taking prenatal vitamins, those with multiple pregnancies, known fetal chromosomal or structural defects, malabsorption conditions, treated thyroid disease, ongoing steroid use, or those not receiving care at Magee-Womens Hospital are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could show that one prenatal formulation produces better maternal nutrient markers and help reduce nutrient deficiencies during pregnancy.
How similar studies have performed: Previous research shows prenatal vitamins generally improve nutrient levels in pregnancy, but direct head-to-head comparisons of specific branded formulations like Perelel versus generics are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Hyagriv Simhan, MD — Magee-Women's Research Institute
- Study coordinator: Jeanette Boyce, RNC, MSN
- Email: tessje@upmc.edu
- Phone: 412-641-4072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.