Recruiting soon
SUPPORT

Comparison of Perelel Trimester-Specific Supplements to Generic Prenatal Vitamins for Maternal and Fetal Health

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study compares Perelel trimester-specific supplements to generic prenatal vitamins to support your health and your baby's development. We will measure various nutritional markers in your blood samples throughout your pregnancy.
What is being tested

Perelel Prenatal Vitamin

+ Generic Prenatal Vitamin
Dietary Supplement
Who is being recruted

Pregnancy

Over 14 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2025

See protocol details

Summary

Principal SponsorUniversity of Pittsburgh
Study ContactJeanette Boyce, RNC, MSN
Last updated: October 6, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

This clinical trial explores whether using Perelel-brand prenatal supplements can lead to better health outcomes for both mothers and their unborn babies compared to generic prenatal supplements. The study focuses on pregnant women, examining how these specific vitamins and minerals might influence important nutritional markers found in blood samples. This research is significant as it could reveal if tailored supplements provide better nutrition during pregnancy, potentially improving maternal and fetal health. Participants in the study will be taking either Perelel or generic prenatal supplements every day throughout their pregnancy. They will visit UPMC Magee-Womens Hospital once during each trimester for blood tests and to answer questions about their health and nutrition. The study will measure changes in nutritional markers from these blood samples to determine the effectiveness of the supplements. Additionally, an observational part of the study will compare blood samples from women experiencing food insecurity to those who are not, providing insights into nutritional differences based on access to food.

Official TitleImpact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial 
Principal SponsorUniversity of Pittsburgh
Study ContactJeanette Boyce, RNC, MSN
Last updated: October 6, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
600 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Over 14 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pregnancy
Criteria
4 inclusion criteria required to participate
Less than 12 weeks' of pregnancy
Receiving care at a Magee-Womens Hospital associated prenatal practice
Identify as having food insecurity
Pregnant with only one baby
5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Group II
Active Comparator
Group III
No Intervention
Study Objectives
Primary Objectives

Assay of Serum 25-hydroxyvitamin D3 in Blood Samples

Assay of Total Folate (RBC) in Blood Samples

Assay of Total Folate (Serum) in Blood Samples

Assay of Serum Ferritin in Blood Samples

Assay of Serum Vitamin B12 in Blood Samples

Assay of Homocysteine in Blood Samples

Assay of Folate Metabolites in Blood Samples
Secondary Objectives

Symptoms of nausea and vomiting will be assessed using the Pregnancy Unique Quantification of Emesis (PUQ-E) questionnaire score. The PUQ-E has a minimum score of 3 and maximum score of 15, with a higher score meaning more severe symptoms.

Symptoms of depression will be assessed using the Edinburg Postnatal Depression Scale (EPDS) questionnaire. The EPDS has a minimum score of 0 and maximum score of 30, with a higher score meaning more severe symptoms.

Symptoms of anxiety will be assessed using the State-Trait Anxiety Inventory (STAI) questionnaire. The STAI has a minimum score of 20 and maximum score of 80, with a higher score meaning more severe symptoms.

Symptoms of stress will be assessed using the Perceived Stress Scale-10 (PSS) questionnaire. The PSS has a minimum score of 0 and maximum score of 40, with a higher score meaning more severe symptoms.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The PSQI has a minimum score of 0 and maximum score of 21, with a higher score meaning worse sleep quality.

General maternal wellness in the third trimester will be assessed using the 36-item short-form (SF36) survey questionnaire. The SF36 has a minimum score of 0 and maximum score of 3600, with a higher score meaning a more favorable state.

Group B strep culture result will be abstracted from the medical record. The result will be positive, negative, or missing/not obtained. There are no unit of measurements involved.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
UPMC Magee-Womens HospitalPittsburgh, United StatesSee the location
Recruiting soonOne Study Center