Recruiting

Postpartum Supplement

Sponsor:

Perelel Inc.

Code:

NCT07303595

Conditions

Postnatal Care

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perelel Mom Multi

Placebo

Study Details

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

Study ID

NCT07303595

Start date

Nov 10, 2025

Status verified date

Dec, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Multivitamin supplement pack

4 capsules and 1 softgel

placebo comparator: Placebo

4 capsules + 1 softgel

Interventions

Perelel Mom Multi

Daily Perelel postnatal multivitamin supplement throughout intervention

Placebo

Daily placebo capsules throughout intervention

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Sina Gallo, PhD, MSc, RD

706-542-4847ctru@uga.edu

Locations

UGA Clinical & Translational Unit

Recruiting

Athens, Georgia, United States, 30606

Contacts

More Information

Sponsor

Perelel Inc.

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Keywords

  • Postnatal
  • multivitamin dietary supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Perelel Inc. on 2025-12-26.