Gummy versus capsule prenatal supplements for women in their second trimester.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will have healthy pregnant women in their second trimester take either a Prenatal Capsule or a Prenatal Gummy every day for 12 weeks and compare outcomes between the two groups. Serum iron will be measured at baseline and again after the 12-week intervention to determine any differences. Eligible participants are 21–40 years old with a gestational age of 14–19 weeks and must be willing and able to take the assigned product daily. Participants with severe nausea/vomiting in the first trimester, inability to tolerate oral supplements, hypersensitivity to study product ingredients, or significant coexisting health conditions are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Atlantia Clinical Trials, Chicago
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator
• Email: sboetto@atlantiatrials.com
• Phone: 312-535 -9440

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.