Mom Multi Postnatal Supplementation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perelel Mom Multi, Placebo.
- Who it may be relevant to
- Registry conditions: Postnatal Care. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing
Overview
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
Interventions
- Dietary supplement Perelel Mom Multi
Daily Perelel postnatal multivitamin supplement throughout intervention - Dietary supplement Placebo
Daily placebo capsules throughout intervention
Primary outcome measures
- 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]
Secondary outcome measures (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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UGA Clinical & Translational Unit — Athens
Identifiers
NCT: NCT07303595 · PROJECT00012011 · Sponsor