Use of Ritual Prenatal Multivitamins for Pregnancy
- Conditions
- Nutrition, HealthyPregnancy Related
- Interventions
- Dietary Supplement: control MVIDietary Supplement: Ritual Epre Multivitamin-mineral supplement
- Registration Number
- NCT05673070
- Lead Sponsor
- City University of New York
- Brief Summary
Prenatal multivitamin/multimineral supplements (MVI) provide important nutrition supplement to the diet of pregnant women to cover potential deficiencies and optimize nutrition status of both mom and baby, especially when the diet is suboptimal or nutrient demand is high while absorption is hindered by various factors such as genetic variance and gastrointestinal function. In this double-blind, randomized, controlled trial, the investigators will recruit 70 pregnant women at gestational week 12-14 and randomly assign them to either receive a Ritual prenatal MVI (n=35) or another commercially available prenatal MVI (n=35) through out pregnancy. Both supplements are over the counter and commercially available. The major differences between the two MVIs are the chemical form of folate as either 5-methyl-tetrahydrofolate or folic acid, and the dosages of vitamin D, biotin, and docosahexaenoic acid. The investigators will collect blood samples in each trimester of pregnancy and the placenta and cord blood at delivery to assess differences in blood nutrient levels. The investigators hypothesize that consumption of Ritual MVI leads to better nutrition status and biomarkers in maternal-fetal dyads compared to control during the antepartum period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 70
Pregnant women are qualified to participate if they are over 18 years of age, having singleton pregnancy, and without any of the conditions listed in the exclusion criteria.
- Exclusion criteria include diabetes, cardiovascular conditions and liver disease prior to and during pregnancy because these diseases affect metabolism of several nutrients and thus may lead to differences in the MVI intake and nutrient status relationship.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control MVI control MVI For the prenatal arm, this group will receive a control multivitamin-mineral supplement pill and a 200 mg docosahexaenoic acid (DHA) pill that are commercially available. Ritual Epre Ritual Epre Multivitamin-mineral supplement This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
- Primary Outcome Measures
Name Time Method Folate status after 24 weeks of intervention The investigators hypothesize that the group that consumes Ritual would have less unmetabolized folic acid in the blood than the control group. A greater proportion of participants would have supranutritional levels of folate (\> 20 ng/mL serum folate) in the control versus Ritual group.
Biotin status after 24 weeks of intervention The investigators hypothesize that the group that consumes Ritual would have higher levels of biotin and lower levels of 3-HIA and 3-HIA-carnitine in the maternal and cord blood than the control group.
placental functional gene expression regulation after 24 weeks of intervention The investigators hypothesize that the group that consumes Ritual would have higher expression of vitamin D response genes and lower expression of inflammatory and stress genes.
vitamin D status after 24 weeks of intervention The investigators hypothesize that the group that consumes Ritual would have higher levels of vitamin D metabolites in the maternal and cord blood than the control group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Brooklyn College of City University of New York
🇺🇸Brooklyn, New York, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States