Postnatal CareNCT07303595
Mom Multi Postnatal Supplementation Trial
A study testing Perelel Mom Multi in people with Postnatal Care, run by Perelel Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Care
- What is being tested?
- Perelel Mom Multi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UGA Clinical & Translational Unit
Athens, Georgia, 30606
Sina Gallo, PHD, 706-713-2721, ctru@uga.edu
About this study
Official title: Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing
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:
Read more
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
- Conditions
- Postnatal Care
- Being tested
- Perelel Mom Multi, Placebo
- Keywords
- Postnatal, multivitamin dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perelel Mom MultiDietary supplement
Daily Perelel postnatal multivitamin supplement throughout intervention
PlaceboDietary supplement
Daily placebo capsules throughout intervention
| Study group | Role | What they receive |
|---|---|---|
| Multivitamin supplement pack | Experimental | 4 capsules and 1 softgel Receives: Dietary Supplement: Perelel Mom Multi |
| Placebo | Placebo comparator | 4 capsules + 1 softgel Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Changes in serum Vitamin D (25-hydroxyvitamin D (25(OH)D) from baseline to end of intervention (12 weeks)
Measured: 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.
Changes in Iron status (serum iron, ferritin, TIBC, transferrin) from baseline to end of intervention (12 weeks)
Measured: 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.
Changes in serum B12 from baseline to end of intervention (12 weeks)
Measured: 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.
Iodine status measured as Maternal Urinary Iodine Concentrations + Creatinine at baseline and 12 weeks
Measured: 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.
Changes in RBC Omega-3 (Total, DHA, and EPA) from baseline to end of intervention (12 weeks)
Measured: 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.
Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)
Measured: 12 weeks
Secondary outcomes (1)
To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.
Change in scores on WHOQOL-BREF questionnaire of maternal mental health/wellbeing outcomes from baseline to end of 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start10 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perelel Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Georgia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303595
- Sponsor's protocol ID
- PROJECT00012011
- Other IDs
- Sponsor
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Postpartum Multivitamin-Mineral Supplement on Maternal Nutrient Status and Wellbeing
- ClinicalTrials.gov ID
- NCT07303595
- Acronym / sponsor ID
- PROJECT00012011
- Conditions
- Postnatal Care
- Keywords
- Postnatal, multivitamin dietary supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Perelel Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Georgia
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multivitamin supplement pack | Experimental | Dietary Supplement: Perelel Mom Multi4 capsules and 1 softgel |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 capsules + 1 softgel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perelel Mom MultiDaily Perelel postnatal multivitamin supplement throughout intervention | Dietary supplement | Multivitamin supplement pack |
| PlaceboDaily placebo capsules throughout intervention | Dietary supplement | Placebo |
Primary outcome
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
Changes in folate status (RBC folate) from baseline to end of intervention (12 weeks)
1 secondary outcome
To assess the effects of the MVM supplement on changes in maternal mental health/wellbeing questionnaire among healthy, postpartum women.
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perelel Mom Multi in people with Postnatal Care, run by Perelel Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sina Gallo, PhD, MSc, RD (706-542-4847, ctru@uga.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.