Health TrialsbyHealthPanel

Mom Multi Postnatal Supplementation Trial

ConditionPostnatal Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPerelel Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perelel Mom Multi

    Dietary supplement

    Daily Perelel postnatal multivitamin supplement throughout intervention

  • Placebo

    Dietary supplement

    Daily placebo capsules throughout intervention

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Multivitamin supplement packExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
12 weeks
2

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)

Time frame
12 weeks
3

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)

Time frame
12 weeks
4

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

Time frame
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

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Perelel Inc.

Lead sponsor

University of Georgia

Collaborator

Source ClinicalTrials.gov
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