Postnatal multivitamin and mineral supplement for new mothers
Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing
We will test whether a postpartum-specific vitamin and mineral supplement helps improve nutrition and health in women who recently gave birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Perelel Inc. Industry-sponsored |
| Locations | 1 site (Athens, Georgia) |
| Trial ID | NCT07303595 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled study will compare a postpartum-specific multivitamin/mineral supplement to a placebo over 12 weeks in women about four weeks after a term singleton birth. Participants will stop other vitamin/mineral supplements, attend two in-person visits at the University of Georgia Clinical & Translational Unit, and complete two phone calls between visits. Blood samples will be collected to measure vitamin and mineral levels, and urine and breastmilk samples are optional for breastfeeding participants; height, weight, and skinfold measures will also be recorded. The sponsor is Perelel Inc. with collaboration from the University of Georgia and the study is conducted at the UGA site in Athens, Georgia.
Who should consider this trial
Good fit: Ideal participants are healthy women about four weeks postpartum (±2 weeks) after a term singleton birth who are not pregnant, can read English or Spanish, and are willing to stop other vitamin/mineral supplements for the 12-week study period.
Not a fit: Women with cardiometabolic disease, prior pregnancy complications (like gestational diabetes or hypertension), malabsorption disorders, current use of medications that affect nutrient absorption, those prescribed postnatal multivitamins by their physician, or with allergies to product ingredients are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the supplement could improve postpartum nutrient levels and related outcomes such as energy, recovery, and support for lactation.
How similar studies have performed: Previous research on prenatal and postpartum multivitamins has shown modest improvements in nutrient levels, but postpartum-specific formulations are less well studied and broad clinical benefits remain limited and mixed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Athens, Georgia
- UGA Clinical & Translational Unit — Athens, Georgia, United States (Recruiting)
Study contacts
- Study coordinator: Sina Gallo, PhD, MSc, RD
- Email: ctru@uga.edu
- Phone: 706-542-4847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.