Mom Multi Postnatal Supplementation Trial

Perelel Inc.

Status: Enrolling

Conditions: Postnatal Care

Treatments: Dietary Supplement: Perelel Mom Multi; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07303595

Sponsor

PROJECT00012011

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Multivitamin supplement pack

Experimental group

Description:

4 capsules and 1 softgel

Treatment:

Dietary Supplement: Perelel Mom Multi

Placebo

Placebo Comparator group

Description:

4 capsules + 1 softgel

Treatment:

Dietary Supplement: Placebo