PregnancyNCT07226414
Prenatal Study in Healthy Pregnant Women
A study testing Prenatal Capsule and Prenatal Gummy in people with Pregnancy, run by Perelel Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Prenatal Capsule and Prenatal Gummy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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))
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator contact
United States1 site, 1 recruiting
- Recruiting
Atlantia Clinical Trials, Chicago
Chicago, Illinois, 60611
Kevin O'Regan Operations Manager, 312-535-9440, koregan@atlantiatrials.com
About this study
Official title: Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
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:
Read more
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
- Conditions
- Pregnancy
- Being tested
- Prenatal Capsule, Prenatal Gummy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal CapsuleDietary supplement
Also called Perelel Prenatal
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 GummyDietary supplement
This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Capsules | Experimental | Prenatal serving is 2 capsules + one omega softgel Receives: Dietary Supplement: Prenatal Capsule |
| Gummy Prenatal | Active comparator | Prenatal serving is 2 gummies that also contains omega Receives: Dietary Supplement: Prenatal Gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to end of intervention on iron levels
Serum iron will be measured as primary outcome
Measured: 12 weeks
Secondary outcomes (4)
Change from baseline to end of intervention on folate status
Change from baseline (Day 1) to end of intervention in Prenatal capsule compared to Comparator product on red blood cell folate
Measured: 12 weeks
Change from baseline to end of intervention on omega-3 status
Change from baseline (Day 1) to end of intervention (Day 85) in Prenatal capsule compared to Comparator product on:
Red Blood Cell (RBC) Omega-3 Index (% Total Omega-3 Fatty Acids) Docosahexaenoic acid (DHA) as a percentage of RBC omega-3 fatty acids Eicosapentaenoic acid (EPA) as a percentage of RBC omega-3 fatty acids
Measured: 12 weeks
Change from baseline to end of intervention on serum Vitamin D
Change from baseline (Day 1) to end of intervention (week 12) in Prenatal capsule compared to Comparator product on Serum Vitamin D (25-hydroxyvitamin D (25(OH)D)
Measured: 12 weeks
Change from baseline to end of intervention on choline status
Change from baseline (Day 1) to end of intervention (Day 85) in Prenatal capsule compared to Comparator product on: Plasma choline, Plasma betaine, and Plasma zinc
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Dec 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perelel Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226414
- Sponsor's protocol ID
- AFCRO-200
- Status last verified
- Dec 2025
- First submitted
- 6 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Perelel Prenatal on Biomarkers in Healthy Pregnant Women.
- ClinicalTrials.gov ID
- NCT07226414
- Acronym / sponsor ID
- AFCRO-200
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Perelel Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prenatal Capsules | Experimental | Dietary Supplement: Prenatal CapsulePrenatal serving is 2 capsules + one omega softgel |
| Gummy Prenatal | Active comparator | Dietary Supplement: Prenatal GummyPrenatal serving is 2 gummies that also contains omega |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal CapsuleAlso: Perelel PrenatalThis 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 Capsules |
| Prenatal GummyThis prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA | Dietary supplement | Gummy Prenatal |
Primary outcome
Change from Baseline to end of intervention on iron levels
Time frame: 12 weeks
Serum iron will be measured as primary outcome
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Capsule and Prenatal Gummy in people with Pregnancy, run by Perelel Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator (312-535 -9440, sboetto@atlantiatrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to end of intervention on iron levels (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.