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NCT Number: NCT07046845

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

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.

Recruiting

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Key information

Conditions

Pregnancy

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Jeanette Boyce Boyce

CONTACT

[email protected]

412-641-4072

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant with only one baby
  • Identify as having food insecurity
  • Receiving care at a Magee-Womens Hospital associated prenatal practice
  • Less than 12 weeks' of pregnancy

Exclusion criteria

  • Currently using prenatal supplement(s)
  • 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

Treatment and study plan

Perelel Prenatal Vitamin

Dietary Supplement

Daily Perelel prenatal vitamin supplement throughout pregnancy

Generic Prenatal Vitamin

Dietary Supplement

Daily generic prenatal vitamin supplement throughout pregnancy.

Primary outcomes

  1. Marker of Maternal Vitamin D Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Serum 25-hydroxyvitamin D3 in Blood Samples

  2. Marker of Maternal Total Folate (RBC) Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Total Folate (RBC) in Blood Samples

  3. Marker of Maternal Total Folate (Serum) Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Total Folate (Serum) in Blood Samples

  4. Marker of Maternal Serum Ferritin Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Serum Ferritin in Blood Samples

  5. Marker of Maternal Serum Vitamin B12 Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Serum Vitamin B12 in Blood Samples

  6. Marker of Maternal Homocysteine Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Homocysteine in Blood Samples

  7. Marker of Maternal Folate Metabolites Nutritional Status

    Time frame: Through study completion, an average of 30 weeks

    Assay of Folate Metabolites in Blood Samples

Secondary outcomes

  1. Symptoms of Nausea and Vomiting in Pregnancy

    Time frame: 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.

  2. Symptoms of Depression in Pregnancy

    Time frame: 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.

  3. Symptoms of Anxiety in Pregnancy

    Time frame: 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.

  4. Symptoms of Stress in Pregnancy

    Time frame: 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.

  5. Sleep Quality in Pregnancy

    Time frame: Through study completion, an average of 30 weeks

    Sleep quality will be assessed using the Global Sleep Assessment Questionnaire (GSAQ). The GSAQ has a minimum score of 0 and a maximum score of 45, with a higher score meaning worse sleep quality.

  6. General Maternal Wellness in Third Trimester

    Time frame: 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.

  7. Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy

    Time frame: 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.

  8. Muscle Cramping Symptoms - Severity

    Time frame: Through study completion, an average of 30 weeks

    Severity of muscle cramping symptoms will be assessed by asking, "How severe were they?" (Visual Analog Scale [VAS] response). The VAS responses include the options: Not Severe at All, A Little Severe, Somewhat Severe, Moderately Severe, Very Severe, all of which will be scored on a gradient using a slider.

  9. Muscle Cramping Symptoms - Frequency

    Time frame: Through study completion, an average of 30 weeks

    Frequency of muscle cramping symptoms will be assessed by asking, "In the past week how many days did you experience leg cramps?" (0-7 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanette Boyce, RNC, MSN

CONTACT

[email protected]

412-641-4072

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Perelel Inc.

Registry information

Official study title

Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial

Acronym: SUPPORT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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