PregnancySUPPORTNCT07046845
Perelel Prenatal Supplements vs. Generic Prenatal Supplements and Health of Mother and Baby (SUPPORT)
A study testing Perelel Prenatal Vitamin and Generic Prenatal Vitamin in people with Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Perelel Prenatal Vitamin and Generic Prenatal Vitamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
Jeanette Boyce Boyce, 412-641-4072, tessje@upmc.edu
About this study
Official title: Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial
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:
Read more
- 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.
- Conditions
- Pregnancy
- Being tested
- Perelel Prenatal Vitamin, Generic Prenatal Vitamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perelel Prenatal VitaminDietary supplement
Daily Perelel prenatal vitamin supplement throughout pregnancy
Generic Prenatal VitaminDietary supplement
Daily generic prenatal vitamin supplement throughout pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Perelel Prenatal Supplement Group | Active comparator | Not described Receives: Dietary Supplement: Perelel Prenatal Vitamin |
| Generic Prenatal Supplement Group | Active comparator | Not described Receives: Dietary Supplement: Generic Prenatal Vitamin |
| Observational Arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marker of Maternal Vitamin D Nutritional Status
Assay of Serum 25-hydroxyvitamin D3 in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Total Folate (RBC) Nutritional Status
Assay of Total Folate (RBC) in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Total Folate (Serum) Nutritional Status
Assay of Total Folate (Serum) in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Serum Ferritin Nutritional Status
Assay of Serum Ferritin in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Serum Vitamin B12 Nutritional Status
Assay of Serum Vitamin B12 in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Homocysteine Nutritional Status
Assay of Homocysteine in Blood Samples
Measured: Through study completion, an average of 30 weeks
Marker of Maternal Folate Metabolites Nutritional Status
Assay of Folate Metabolites in Blood Samples
Measured: Through study completion, an average of 30 weeks
Secondary outcomes (9)
Symptoms of Nausea and Vomiting in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
Symptoms of Depression in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
Symptoms of Anxiety in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
Symptoms of Stress in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
Sleep Quality in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
General Maternal Wellness in Third Trimester
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.
Measured: Through study completion, an average of 30 weeks
Result of Clinically Reported Lab Tests of Group B Strep Culture in Pregnancy
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.
Measured: Through study completion, an average of 30 weeks
Muscle Cramping Symptoms - Severity
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.
Measured: Through study completion, an average of 30 weeks
Muscle Cramping Symptoms - Frequency
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)
Measured: Through study completion, an average of 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start7 Jan 2026
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Perelel Inc.
- Responsible party
- Principal investigator, Hyagriv Simhan, University of Pittsburgh
- Investigators
- Hyagriv Simhan, MD, Principal investigator, Magee-Women's Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046845
- Sponsor's protocol ID
- STUDY25020013
- Acronym
- SUPPORT
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perelel Trimester-Specific Dietary Supplements vs. Generic Prenatal Supplements on Maternal and Fetal Health Outcomes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07046845
- Acronym / sponsor ID
- SUPPORT / STUDY25020013
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Perelel Inc.
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perelel Prenatal Supplement Group | Active comparator | Dietary Supplement: Perelel Prenatal Vitamin |
| Generic Prenatal Supplement Group | Active comparator | Dietary Supplement: Generic Prenatal Vitamin |
| Observational Arm | No intervention | – |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perelel Prenatal VitaminDaily Perelel prenatal vitamin supplement throughout pregnancy | Dietary supplement | Perelel Prenatal Supplement Group |
| Generic Prenatal VitaminDaily generic prenatal vitamin supplement throughout pregnancy. | Dietary supplement | Generic Prenatal Supplement Group |
Primary outcome
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
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
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
Marker of Maternal Serum Ferritin Nutritional Status
Time frame: Through study completion, an average of 30 weeks
Assay of Serum Ferritin in Blood Samples
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
Marker of Maternal Homocysteine Nutritional Status
Time frame: Through study completion, an average of 30 weeks
Assay of Homocysteine in Blood Samples
Marker of Maternal Folate Metabolites Nutritional Status
Time frame: Through study completion, an average of 30 weeks
Assay of Folate Metabolites in Blood Samples
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyagriv Simhan, MD principal investigator
Magee-Women's Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perelel Prenatal Vitamin and Generic Prenatal Vitamin in people with Pregnancy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette Boyce, RNC, MSN (412-641-4072, tessje@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marker of Maternal Vitamin D Nutritional Status (time frame: Through study completion, an average of 30 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.