Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-11-10
2026-10-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Multivitamin supplement pack
4 capsules and 1 softgel
Perelel Mom Multi
Daily Perelel postnatal multivitamin supplement throughout intervention
Placebo
4 capsules + 1 softgel
Placebo
Daily placebo capsules throughout intervention
Interventions
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Perelel Mom Multi
Daily Perelel postnatal multivitamin supplement throughout intervention
Placebo
Daily placebo capsules throughout intervention
Eligibility Criteria
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Inclusion Criteria
* Not pregnant during the study period
* Able to understand (written and spoken) English or Spanish.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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University of Georgia
OTHER
Perelel Inc.
INDUSTRY
Responsible Party
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Locations
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UGA Clinical & Translational Unit
Athens, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Sina Gallo, PHD
Role: primary
Other Identifiers
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Sponsor
Identifier Type: OTHER
Identifier Source: secondary_id
PROJECT00012011
Identifier Type: -
Identifier Source: org_study_id