Prenatal Supplements for Pregnancy
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.12345Why 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.678910Are 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take their assigned prenatal supplement (either Prenatal Capsule or the comparator Prenatal Gummy) daily for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
Prenatal serving is 2 capsules + one omega softgel
Prenatal serving is 2 gummies that also contains omega
Find a Clinic Near You
Who Is Running the Clinical Trial?
Perelel Inc.
Lead Sponsor
Citations
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 ...
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 ...
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/fullPrenatal 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 ...
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 ...
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.
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-dosesPrenatal 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 ...
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.
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.
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