Mom Multi Postnatal Supplementation Trial

NCT07303595 | Recruiting

• 2 other identifiers: PROJECT00012011Sponsor
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postnatal Care

Keywords

Postnatal; multivitamin dietary supplement

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)

  12 weeks

Secondary Outcomes (1)

• To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.

  12 weeks

Study Arms (2)

Multivitamin supplement pack

EXPERIMENTAL

4 capsules and 1 softgel

Dietary Supplement: Perelel Mom Multi

Placebo

PLACEBO COMPARATOR

4 capsules + 1 softgel

Dietary Supplement: Placebo

Interventions

Perelel Mom Multi DIETARY_SUPPLEMENT

Daily Perelel postnatal multivitamin supplement throughout intervention

Multivitamin supplement pack

Placebo DIETARY_SUPPLEMENT

Daily placebo capsules throughout intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Perelel Inc.: lead
• University of Georgia: collaborator

Study Sites (1)

UGA Clinical & Translational Unit

Athens, Georgia, 30606, United States

RECRUITING

Central Study Contacts

Sina Gallo, PhD, MSc, RD

CONTACT

706-542-4847; ctru@uga.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: December 26, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)