Recruiting

Pregnancy Supplement Study in Healthy Pregnant Women

Sponsor:

Perelel Inc.

Code:

NCT07226414

Conditions

Pregnancy

Eligibility Criteria

Sex: Female

Age: 21 - 40

Interventions

Pregnancy Capsule Supplement

Pregnancy Gummy Supplement

Study Details

Brief summary:

Clinical Trial Summary

The goal of this clinical trial is to address the impact of a gummy pregnancy supplement vs a capsule supplement in pregnant women. The main question it aims to answer is:
Does 12-week daily administration of a pregnancy capsule supplement affect serum iron levels in pregnant women in their second trimester compared to a comparator gummy supplement?
Participants will:
• Take their assigned supplement (either pregnancy capsule supplement or the comparator gummy supplement) daily for 12 weeks

• Be in their second trimester of pregnancy (14–19 weeks)

• Have their serum iron levels measured at baseline and after the 12-week intervention period

Conditions

Pregnancy

Study ID

NCT07226414

Start date

Dec 1, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 40

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pregnancy Capsule Supplement

Pregnancy serving is 2 capsules + one omega softgel

active comparator: Gummy Pregnancy Supplement

Pregnancy serving is 2 gummies that also contains omega

Interventions

Pregnancy Capsule Supplement

This study will look at the impacts of a pregnancy capsule supplement vs a gummy comparator pregnancy supplement. The pregnancy supplement consists of 2 multivitamin + micronutrient blend with one omega softgel.

Pregnancy Gummy Supplement

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

Primary outcome measure

  • Change from Baseline to end of intervention on iron levels [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dr. Stacey Boetto, DNP, FNP-C Clinical Research Investigator

312-535 -9440sboetto@atlantiatrials.com

Locations

Atlantia Clinical Trials, Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Kevin O'Regan Operations Manager

312-535-9440koregan@atlantiatrials.com

More Information

Sponsor

Perelel Inc.

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-04. This information was provided to ClinicalTrials.gov by Perelel Inc. on 2025-12-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.