Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-12-31
2026-11-30
Brief Summary
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The goal of this clinical trial is to address the impact of a gummy prenatal vs a capsule based prenatal in pregnant women. The main question it aims to answer is:
Does 12-week daily administration of Prenatal Capsule affect serum iron levels in pregnant women in their second trimester compared to a comparator gummy prenatal?
Researchers will compare Prenatal Capsule to a comparator Prenatal Gummy to see if there are differences in serum iron levels after 12 weeks of daily use.
Participants will:
Take their assigned prenatal supplement (either Prenatal Capsule or the comparator Prenatal Gummy) daily for 12 weeks Be in their second trimester of pregnancy during the study period Have their serum iron levels measured at baseline and after the 12-week intervention period
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Prenatal Capsules
Prenatal serving is 2 capsules + one omega softgel
Prenatal Capsule
This study will look at the impacts of a prenatal capsule vs a gummy comparator prenatal. The prenatal consists of 2 multivitamin + micronutrient blend with one omega softgel.
Gummy Prenatal
Prenatal serving is 2 gummies that also contains omega
Prenatal Gummy
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
Interventions
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Prenatal Capsule
This study will look at the impacts of a prenatal capsule vs a gummy comparator prenatal. The prenatal consists of 2 multivitamin + micronutrient blend with one omega softgel.
Prenatal Gummy
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Willing to consume the Study Product daily for the duration of the study.
Exclusion Criteria
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.
Excluded health conditions include:
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.
21 Years
40 Years
FEMALE
No
Sponsors
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Perelel Inc.
INDUSTRY
Responsible Party
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Locations
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Atlantia Clinical Trials, Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
Role: CONTACT
Phone: 312-535 -9440
Email: [email protected]
Facility Contacts
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Kevin O'Regan Operations Manager
Role: primary
Other Identifiers
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AFCRO-200
Identifier Type: -
Identifier Source: org_study_id