Gummy versus capsule prenatal supplements for women in their second trimester.
Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
NA · Perelel Inc. · NCT07226414
This will test whether taking a daily capsule or a daily gummy prenatal for 12 weeks changes blood iron levels in women in their second trimester of pregnancy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 40 Years |
| Sex | Female |
| Sponsor | Perelel Inc. (industry) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07226414 on ClinicalTrials.gov |
What this trial studies
Researchers will have healthy pregnant women in their second trimester take either a Prenatal Capsule or a Prenatal Gummy every day for 12 weeks and compare outcomes between the two groups. Serum iron will be measured at baseline and again after the 12-week intervention to determine any differences. Eligible participants are 21–40 years old with a gestational age of 14–19 weeks and must be willing and able to take the assigned product daily. Participants with severe nausea/vomiting in the first trimester, inability to tolerate oral supplements, hypersensitivity to study product ingredients, or significant coexisting health conditions are excluded.
Who should consider this trial
Good fit: Healthy pregnant women aged 21–40 in their second trimester (14–19 weeks) who can give informed consent and are willing to take a daily prenatal supplement for 12 weeks.
Not a fit: Women with severe nausea or vomiting, inability to tolerate oral supplements, hypersensitivity to the product ingredients, or significant coexisting health conditions are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this could help pregnant women and clinicians choose whether a capsule or a gummy better maintains blood iron during the second trimester.
How similar studies have performed: Prior research on iron absorption from different supplement formulations has shown mixed results, and direct comparisons of gummy versus capsule prenatal products for serum iron are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be able to give written informed consent. * Healthy pregnant women between 21- 40 years of age (inclusive). * Pregnant women in the second trimester of pregnancy (gestational age of 14-19 weeks). * Willing to consume the Study Product daily for the duration of the study. Exclusion Criteria: * History of drug or alcohol abuse * Is hypersensitive to any of the contents of the study product, that would preclude intake of the study products. * Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk, or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. * Severe nausea and vomiting in the first trimester, including hyperemesis gravidarum (HG) * Inability to tolerate oral supplement intake due to gastrointestinal symptoms during the first trimester of pregnancy * Prior Pregnancy Complications (gestational diabetes (GD), HG, or pre-eclampsia, NTDs (Neural Tube Defects)) * Current pregnancy complications (GD, Iron Deficiency Anemia) * Hypertension * Diabetes mellitus * Cardiovascular disease * Class II/III obesity (defined as BMI ≥35.0 Kg/m2) * Malabsorption syndromes (e.g., celiac disease, inflammatory bowel disease) * Severe anemia or iron overload disorders * Thyroid disorders * Current or recent (in the past 12 weeks prior to Visit 1) use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results, as judged by the investigator. Prohibited medications include: Medications that contain fat-soluble vitamins A, E, or K in high doses \- Current or recent (in the past 12 weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results as judged by the investigator.
Where this trial is running
Chicago, Illinois
- Atlantia Clinical Trials, Chicago — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
- Email: sboetto@atlantiatrials.com
- Phone: 312-535 -9440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pregnancy