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

Not Applicable

Not yet recruiting

• Conditions: Pregnancy

• Registration Number: NCT07046845
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-05
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Study Start: 2025-09-01
• Primary Completion: 2026-12
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Marker of Maternal Total Folate (RBC) Nutritional Status	Through study completion, an average of 30 weeks	Assay of Total Folate (RBC) in Blood Samples
Marker of Maternal Total Folate (Serum) Nutritional Status	Through study completion, an average of 30 weeks	Assay of Total Folate (Serum) in Blood Samples
Marker of Maternal Serum Ferritin Nutritional Status	Through study completion, an average of 30 weeks	Assay of Serum Ferritin in Blood Samples
Marker of Maternal Homocysteine Nutritional Status	Through study completion, an average of 30 weeks	Assay of Homocysteine in Blood Samples
Marker of Maternal Folate Metabolites Nutritional Status	Through study completion, an average of 30 weeks	Assay of Folate Metabolites in Blood Samples
Marker of Maternal Vitamin D Nutritional Status	Through study completion, an average of 30 weeks	Assay of Serum 25-hydroxyvitamin D3 in Blood Samples
Marker of Maternal Serum Vitamin B12 Nutritional Status	Through study completion, an average of 30 weeks	Assay of Serum Vitamin B12 in Blood Samples

Secondary Outcome Measures

Name	Time	Method
Symptoms of Nausea and Vomiting in Pregnancy	Through study completion, an average of 30 weeks	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 Stress in Pregnancy	Through study completion, an average of 30 weeks	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 in Pregnancy	Through study completion, an average of 30 weeks	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.
Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy	Through study completion, an average of 30 weeks	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.
Symptoms of Anxiety in Pregnancy	Through study completion, an average of 30 weeks	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.
General Maternal Wellness in Third Trimester	Through study completion, an average of 30 weeks	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.
Symptoms of Depression in Pregnancy	Through study completion, an average of 30 weeks	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.

Trial Locations

Locations (1)

UPMC Magee-Womens Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States