Health TrialsbyHealthPanel

Prenatal Study in Healthy Pregnant Women

ConditionPregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-40
SponsorPerelel Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prenatal Capsule

    Dietary supplement

    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

    Dietary supplement

    This prenatal gummy is a commercially available multivitamin that also contains omega-3 DHA and EPA

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Prenatal CapsulesExperimental treatment 1 intervention
Group B: Gummy PrenatalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline to end of intervention on iron levels

Serum iron will be measured as primary outcome

Time frame
12 weeks

Secondary outcomes

1

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

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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)

Time frame
12 weeks
4

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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Perelel Inc.

Lead sponsor

Source ClinicalTrials.gov
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