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Recruiting

NCT Number: NCT07303595

Mom Multi Postnatal Supplementation Trial

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

Recruiting

Interested in participating?

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Key information

Conditions

Postnatal Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UGA Clinical & Translational Unit

Athens, Georgia, 30606, United States

Location status: Recruiting

Location contact

Sina Gallo, PHD

CONTACT

[email protected]

706-713-2721

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Perelel Mom Multi

Dietary Supplement

Daily Perelel postnatal multivitamin supplement throughout intervention

Placebo

Dietary Supplement

Daily placebo capsules throughout intervention

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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)

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sina Gallo, PhD, MSc, RD

CONTACT

[email protected]

706-542-4847

Sponsors and collaborators

Lead sponsor

Perelel Inc.

Industry

Collaborators

  • University of Georgia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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