Prenatal Supplements for Pregnancy

Overseen By Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Perelel Inc.

Must not be taking: High-dose vitamins

Disqualifiers: Hypertension, Diabetes, Obesity, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a prenatal capsule or gummy supplement affects iron levels in pregnant women during their second trimester. The study measures iron levels at the start and after 12 weeks of daily use of either the capsule or gummy. Women in their second trimester without complications such as gestational diabetes or severe nausea may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to important research that could enhance prenatal care options.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot take medications with high doses of vitamins A, E, or K, or any supplements that might interfere with the study. It's best to discuss your current medications with the study team to see if they are allowed.

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

Research shows that prenatal vitamins, whether in capsule or gummy form, are generally safe for pregnant women when used correctly. Studies have found that both types may contain trace amounts of heavy metals like lead and cadmium, but these amounts are usually too low to be a concern.

For prenatal capsules, some reports suggest that taking very high doses of certain ingredients, such as folic acid, might raise blood pressure over time. However, this risk is mainly associated with doses higher than typically recommended.

Prenatal gummies contain similar levels of heavy metals, which remain low and are not expected to be harmful when used normally.

Overall, prenatal vitamins in both capsule and gummy forms are considered safe when taken as directed during pregnancy. Consulting with a healthcare provider ensures the supplement meets individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these prenatal supplements because they offer a fresh take on ensuring essential nutrient intake during pregnancy. The Prenatal Capsule combines two capsules with an omega softgel, potentially simplifying the supplement routine for expectant mothers who prefer a pill form. Meanwhile, the Gummy Prenatal offers a convenient and palatable option for those who might struggle with swallowing pills, while still delivering the needed omega nutrients. These variations provide flexibility and cater to different preferences, which could improve adherence to prenatal vitamin regimens.

What evidence suggests that this trial's treatments could be effective for improving serum iron levels in pregnant women?

This trial will compare Prenatal Capsules with Gummy Prenatal supplements. Studies have shown that prenatal supplements can greatly benefit pregnant women by reducing the risk of birth defects and aiding in the baby's growth. For participants receiving Prenatal Capsules, evidence suggests they might help lower the risk of anemia (a low red blood cell count), high blood pressure during pregnancy (preeclampsia), and other issues. Research indicates that taking a daily dose of certain nutrients in capsules can be very effective for these benefits.

Participants receiving Gummy Prenatal vitamins might find them appealing due to their taste and ease of use, but they often lack iron, which is important for preventing anemia. This difference in iron content might affect their ability to maintain or improve iron levels in the blood during pregnancy. Both types of supplements aim to support a healthy pregnancy, but capsules might be better for meeting iron needs. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy pregnant women in their second trimester. Participants will take a daily prenatal supplement, either in capsule or gummy form, and have their serum iron levels checked before and after the 12-week study period.

Inclusion Criteria

Be able to give written informed consent

Willing to consume the Study Product daily for the duration of the study

I am a healthy pregnant woman aged between 21 and 40.

Exclusion Criteria

Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects))

History of drug or alcohol abuse

Hypersensitivity to any of the contents of the study product that would preclude intake of the study products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take their assigned prenatal supplement (either Prenatal Capsule or the comparator Prenatal Gummy) daily for 12 weeks

12 weeks

Baseline and end of intervention visits for serum iron measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prenatal Capsule
• Prenatal Gummy

Trial Overview The study is testing whether there's a difference between taking a Prenatal Capsule versus a Prenatal Gummy on serum iron levels over 12 weeks of daily use among pregnant women in their second trimester.

How Is the Trial Designed?

Group I: Prenatal Capsules Experimental Treatment 1 Intervention

Prenatal serving is 2 capsules + one omega softgel

Group II: Gummy Prenatal Active Control 1 Intervention

Prenatal serving is 2 gummies that also contains omega

Who Is Running the Clinical Trial?

Perelel Inc.

Lead Sponsor

Trials

2

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10866212/

A critical evaluation of prenatal supplements: Are they meeting ... Our analysis suggests that while prenatal supplements can offer important benefits, including reduced risk of birth defects and improved fetal growth and ...

2. mhnpjournal.biomedcentral.com mhnpjournal.biomedcentral.com/articles/10.1186/s40748-022-00139-9

Evidence based recommendations for an optimal prenatal ... This recommendation appears likely to reduce the risk of premature rupture of membranes and may reduce the risk of anemia, preeclampsia, urinary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275129/

Evidence based recommendations for an optimal prenatal ... Altogether, the data suggests that 100 mg/day is effective, and somewhat more may be beneficial. Quality of evidence. High. Strength of recommendation to ...

4. frontiersin.org frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2024.1474928/full

Prenatal vitamin utilization and its determinants among ... This study aimed to assess utilization and associated factors of prenatal vitamins among pregnant women attending antenatal care at public hospitals in the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622101951

Pill Count Adherence to Prenatal Multivitamin/Mineral ... Adherence to supplement use was assessed by pill counts among 244 pregnant women of 867 women who were initially randomized to receive 1 of 3 prenatal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10874124/

Toxic element contaminations of prenatal vitamins - PMC The vitamin pills we analyzed have elevated levels of boron, aluminum, molybdenum, barium, lead, titanium, nickel, arsenic, strontium, and cadmium.

7. gao.gov gao.gov/products/gao-24-106689

Prenatal Supplements: Amounts of Some Key Nutrients ... GAO found trace amounts of two heavy metals—lead or cadmium—in half of the tested prenatal supplements (six of 12), but not in amounts likely to ...

8. heart.org heart.org/en/news/2020/05/11/prenatal-supplement-may-increase-blood-pressure-at-high-doses

Prenatal supplement may increase blood pressure at high ... Women who take high-dose folic acid supplements from pre-pregnancy through mid-pregnancy might increase their risk for potentially dangerous high blood ...

9. my.clevelandclinic.org my.clevelandclinic.org/health/drugs/9754-pregnancy-prenatal-vitamins

Prenatal Vitamins: Importance, Deficiency & Essentials Do prenatals make you gain weight if you're not pregnant? No. There isn't any data that supports a prenatal vitamin will make you gain weight.

10. cdc.gov cdc.gov/medicine-and-pregnancy/about/index.html

Medicine and Pregnancy: An Overview Certain medicines during pregnancy can increase the risk for health problems, such as some birth defects, prematurity, or pregnancy loss.