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
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
Treatments tested in this trial
- Prenatal Capsule
- Prenatal Gummy
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov