Mom Multi Postnatal Supplementation Trial

December 10, 2025 updated by: Perelel Inc.

Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing

The goal of this clinical trial is to learn if a vitamin and mineral supplement designed specifically for women after childbirth can improve their nutrition and health in women who are pregnant or have recently given birth (within 6 weeks).

The main question it aims to answer is:

Can a postpartum-specific vitamin and mineral supplement help improve nutritional status and health outcomes in women after giving birth?

Researchers will compare women who take the new postpartum vitamin and mineral supplement to women who take a placebo (fake pills without active ingredients) to see if the supplement improves their nutritional health.

Participants will:

Attend 2 visits at University of Georgia (1-1.5 hours each) over 12 weeks Participate in 2 phone calls between visits Stop taking other vitamin/mineral supplements during the study Have blood drawn to test vitamin and mineral levels Provide urine samples and breastmilk samples if breastfeeding (optional) Have height, weight, and skin color measured Complete questionnaires about health, pregnancy, and mental wellness Answer questions about daily food and drink intake Take either the study supplement or placebo daily

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sina Gallo, PhD, MSc, RD
  • Phone Number: 706-542-4847
  • Email: ctru@uga.edu

Study Locations

  • United States
    • Georgia
      • Athens, Georgia, United States, 30606
        • Recruiting
        • UGA Clinical & Translational Unit
        • Contact:
          • Sina Gallo, PHD
          • Phone Number: 706-713-2721
          • Email: ctru@uga.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Healthy, postpartum women (~4 weeks [± 2 weeks]) with infants born term and singleton
  • Not pregnant during the study period
  • Able to understand (written and spoken) English or Spanish.

Exclusion criteria:

  • Cardiometabolic disease
  • Past pregnancy complications (gestational diabetes, hypertension)
  • malabsorption syndromes (IBS, IBD, Crohn's, Colitis, Celiac)
  • Caily use of medications which may affect nutrient absorption
  • chronic alcohol use (> 4 alcoholic drinks/day)
  • those prescribed postnatal MVM supplements by their physician
  • unwilling to discontinue dietary supplementation containing any of the active components in the study product over the study period
  • Women should not have an allergy or intolerance to active or inactive product ingredients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multivitamin supplement pack
4 capsules and 1 softgel
Dietary supplement: Perelel Mom Multi
Daily Perelel postnatal multivitamin supplement throughout intervention
Placebo Comparator: Placebo
4 capsules + 1 softgel
Dietary supplement: Placebo
Daily placebo capsules throughout intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin D status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Changes in serum Vitamin D (25-hydroxyvitamin D (25(OH)D) from baseline to end of intervention (12 weeks)
12 weeks
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iron status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Changes in Iron status (serum iron, ferritin, TIBC, transferrin) from baseline to end of intervention (12 weeks)
12 weeks
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Vitamin B12 status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Changes in serum B12 from baseline to end of intervention (12 weeks)
12 weeks
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal iodine status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Iodine status measured as Maternal Urinary Iodine Concentrations + Creatinine at baseline and 12 weeks
12 weeks
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal Omega-3 status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Changes in RBC Omega-3 (Total, DHA, and EPA) from baseline to end of intervention (12 weeks)
12 weeks
To assess the effects of the multi-vitamin-mineral (MVM) supplement on changes in maternal folate status as compared to placebo among healthy, postpartum women.
Time Frame: 12 weeks
Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.
Time Frame: 12 weeks
Change in scores on WHOQOL-BREF questionnaire of maternal mental health/wellbeing outcomes from baseline to end of 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Perelel Inc.

Collaborators

University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 2, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROJECT00012011
  • Sponsor (Other Grant/Funding Number: China National Center for Cardiovascular Diseases)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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