Postnatal Care
Conditions
Keywords
Postnatal, multivitamin dietary supplement
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
Interventions
DIETARY_SUPPLEMENTPerelel Mom Multi
Daily Perelel postnatal multivitamin supplement throughout intervention
DIETARY_SUPPLEMENTPlacebo
Daily placebo capsules throughout intervention
Sponsors
University of Georgia
Perelel Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 weeks | Changes in serum Vitamin D (25-hydroxyvitamin D (25(OH)D) from baseline to end of intervention (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. | 12 weeks | Changes in Iron status (serum iron, ferritin, TIBC, transferrin) from baseline to end of intervention (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. | 12 weeks | Changes in serum B12 from baseline to end of intervention (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. | 12 weeks | Iodine status measured as Maternal Urinary Iodine Concentrations + Creatinine at baseline and 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. | 12 weeks | Changes in RBC Omega-3 (Total, DHA, and EPA) from baseline to end of intervention (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. | 12 weeks | Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women. | 12 weeks | Change in scores on WHOQOL-BREF questionnaire of maternal mental health/wellbeing outcomes from baseline to end of 12 weeks |
Countries
United States
Contacts
Primary ContactSina Gallo, PhD, MSc, RD
Outcome results
None listed