Perelel vs Generic Prenatal Vitamins for Pregnancy

(SUPPORT Trial)

Overseen By Jeanette Boyce, RNC, MSN

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must not be taking: Prenatal supplements, Steroids

Disqualifiers: Thyroid disorder, Nutrient absorption, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 30 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Perelel-brand prenatal vitamins are more effective than generic ones in improving maternal and fetal health during pregnancy. Researchers will assess the impact of these supplements on nutritional markers in blood samples. Participants will take either Perelel or generic vitamins daily and visit the hospital once each trimester for a blood test and questionnaire. Ideal candidates are pregnant women less than 12 weeks along, expecting one baby, and experiencing food insecurity. An observational component also examines the effects of food insecurity during the first trimester.

As an unphased trial, this study allows participants to contribute to important research that could enhance prenatal care for future mothers.

Do I need to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already using prenatal supplements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Perelel prenatal vitamins are produced in FDA-approved facilities and undergo strict safety testing. The company ensures these vitamins are free from harmful heavy metals and are formulated by leading women's health doctors. This commitment to safety and quality makes these vitamins generally safe for use during pregnancy.

Generic prenatal vitamins are also widely used and usually considered safe, as they contain essential vitamins and minerals needed during pregnancy. However, safety details can vary based on the brand and ingredients.

Both Perelel and generic prenatal vitamins aim to support a healthy pregnancy, but individual tolerance can vary. If concerns arise, consulting a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Perelel Prenatal Vitamin because it offers a tailored approach to prenatal nutrition. Unlike generic prenatal vitamins that provide a one-size-fits-all formula, Perelel provides targeted nutrient blends specific to different stages of pregnancy. This customization ensures that expectant mothers receive optimal nutrition tailored to their trimester, potentially improving maternal and fetal health outcomes. Additionally, the use of high-quality, bioavailable ingredients in Perelel may enhance nutrient absorption, setting it apart from standard prenatal vitamin options.

What evidence suggests that this trial's treatments could be effective for pregnancy?

This trial will compare Perelel Prenatal Vitamins with Generic Prenatal Vitamins. Studies have shown that prenatal vitamins, such as Perelel, offer important benefits during pregnancy. Perelel supplements are specially formulated to provide the right nutrients for each stage of pregnancy. For instance, they include Vitamin D3, which research has shown is more effective at increasing and maintaining vitamin levels than other forms. This focus on specific nutrients can alleviate pregnancy symptoms, like nausea, and support the health of both mother and baby. While regular prenatal vitamins also aid during pregnancy, Perelel's targeted approach may offer additional benefits by providing nutrients tailored to each trimester. ^{6 7 8 9 10}

Who Is on the Research Team?

Hyagriv Simhan, MD

Principal Investigator

Magee-Women's Research Institute

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who can take daily prenatal supplements and visit UPMC Magee-Womens Hospital once every trimester. It's not specified who can't join, but typically those with health conditions affecting nutrient absorption or allergies to supplement ingredients might be excluded.

Inclusion Criteria

Pregnant with only one baby

Identify as having food insecurity

Receiving care at a Magee-Womens Hospital associated prenatal practice

Exclusion Criteria

Currently using prenatal supplement(s)

My unborn baby has been diagnosed with a genetic or structural issue.

I cannot absorb nutrients from food properly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take either Perelel or generic prenatal supplements daily throughout pregnancy

30 weeks

3 visits (in-person, once every trimester)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Generic Prenatal Vitamin
• Perelel Prenatal Vitamin

Trial Overview

The study compares the effects of Perelel-brand prenatal vitamins against generic ones on mother and baby health during pregnancy. Participants will take one type of supplement throughout their pregnancy and have blood tests each trimester to check nutritional markers.

How Is the Trial Designed?

Group I: Perelel Prenatal Supplement Group Active Control 1 Intervention

Group II: Generic Prenatal Supplement Group Active Control 1 Intervention

Group III: Observational Arm Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Perelel Inc.

Industry Sponsor

Trials

2

Recruited

100+

Citations

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perelelhealth.com/blogs/news/prenatal-vitamins-ingredients?srsltid=AfmBOoplGy4gHT_j16TCAJDsemr8UO7xb2gOEZNOiBExPm2YE5Jo-qut

The Ingredients Every Prenatal Vitamin Needs

Perelel opted to formulate with cholecalciferol because research shows that Vitamin D3 is more effective than Vitamin D2 in increasing and maintaining higher ...

2.

fertilefacts.com

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Perelel Conception Pack Review - We tried it, Should You?

Overall, we recommend Perelel's daily prenatal products for anyone looking to optimize their nutrition and health for conception with high-quality, research- ...

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perelelhealth.com/blogs/news/benefits-of-prenatal-vitamins?srsltid=AfmBOoqxK-CRTREUZJQsqL4lw-UwzjEzvfrdXfrRaeNJqb6tQiIpYlqF

10 Proven Benefits of Prenatal Vitamins

Wondering what prenatal vitamins really do? We've got the data. Read on for 10 proven benefits of prenatal vitamins.

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Complete Support for 1st Trimester Pregnancy

this bundle provides comprehensive support for the 1st trimester—targeting pregnancy nausea, stage-specific nutrients, fiber requirements, and optimal hydration ...

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patlynk.com

patlynk.com/trial/NCT07046845

Comparison of Perelel Trimester-Specific Supplements to ...

This clinical trial explores whether using Perelel-brand prenatal supplements can lead to better health outcomes for both mothers and their unborn babies ...

6.

perelelhealth.com

perelelhealth.com/pages/label-checker?srsltid=AfmBOooGkXSSFodoxHhRBHNHsCHL8tr2zNVHwm464YsWcBFvmXRaESqf

Label Checker – Verify Ingredients & Quality of Supplements

Make empowered, informed decisions about your health. Select your product type + paste your ingredient list below to see if it's pregnancy-safe.

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Safety & Testing for Prenatal & Women's Health Vitamins

Rest assured, Perelel vitamins are made in FDA-approved facilities and rigorously tested for safety. Learn more about our commitment to quality and safety.

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Decoding Heavy Metals: Let's Talk About Supplement Safety

Perelel holds itself to the highest heavy metal standards. Every Perelel product is meticulously formulated with the help of our panel of leading OB/GYNs.

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perelelhealth.com

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Prenatals - First Trimester Pregnancy Supplements

1st Trimester Prenatal Pack · Formulated by OB/GYNs · Support baby's early development* · Helps reduce morning sickness* · No nausea formula · HSA | FSA Accepted.

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FAQ

Our Prenatal Multivitamins Packs packs are all safe for pregnancy: 1st Trimester Prenatal Pack · 2nd Trimester Prenatal Pack · 3rd Trimester Prenatal Pack · 1st ...