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Recruiting NCT07046845

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

No phase Interventional Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perelel Prenatal Vitamin, Generic Prenatal Vitamin.
Who it may be relevant to
Registry conditions: Pregnancy. Basic parameters: from 14 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement Perelel Prenatal Vitamin
    Daily Perelel prenatal vitamin supplement throughout pregnancy
  • Dietary supplement Generic Prenatal Vitamin
    Daily generic prenatal vitamin supplement throughout pregnancy.

Primary outcome measures

  • Marker of Maternal Vitamin D Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Total Folate (RBC) Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Total Folate (Serum) Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Serum Ferritin Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Serum Vitamin B12 Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Homocysteine Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
  • Marker of Maternal Folate Metabolites Nutritional Status [Time frame: Through study completion, an average of 30 weeks]
Secondary outcome measures (9)
  • Symptoms of Nausea and Vomiting in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • Symptoms of Depression in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • Symptoms of Anxiety in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • Symptoms of Stress in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • Sleep Quality in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • General Maternal Wellness in Third Trimester [Time frame: Through study completion, an average of 30 weeks]
  • Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy [Time frame: Through study completion, an average of 30 weeks]
  • Muscle Cramping Symptoms - Severity [Time frame: Through study completion, an average of 30 weeks]
  • Muscle Cramping Symptoms - Frequency [Time frame: Through study completion, an average of 30 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • UPMC Magee-Womens Hospital — Pittsburgh

Identifiers

NCT: NCT07046845 · STUDY25020013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗