Prenatal Study in Healthy Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prenatal Capsule, Prenatal Gummy.
- Who it may be relevant to
- Registry conditions: Pregnancy. Basic parameters: 21 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
Overview
Clinical Trial Summary 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
Interventions
- Dietary supplement 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. - Dietary supplement Prenatal Gummy
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
Primary outcome measures
- Change from Baseline to end of intervention on iron levels [Time frame: 12 weeks]
Secondary outcome measures (4)
- Change from baseline to end of intervention on folate status [Time frame: 12 weeks]
- Change from baseline to end of intervention on omega-3 status [Time frame: 12 weeks]
- Change from baseline to end of intervention on serum Vitamin D [Time frame: 12 weeks]
- Change from baseline to end of intervention on choline status [Time frame: 12 weeks]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Atlantia Clinical Trials, Chicago — Chicago
Identifiers
NCT: NCT07226414 · AFCRO-200