Clinical trial NCT05673070: Use of Ritual Prenatal Multivitamins for Pregnancy
Official title: Use of Ritual Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Nutrition, Healthy
Lead sponsor: City University of New York
Sponsor class: OTHER
Collaborators: name: Maimonides Medical Center
First posted: 2023-01-06
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prenatal arm: pregnant women at gestational week 12-14 will be randomized to either receive a Ritual prenatal MVI (n=35) or a control commercially available prenatal MVI (n=35) through out pregnancy
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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:

* 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.

Primary outcomes:
measure: Folate status
timeFrame: after 24 weeks of intervention
measure: Biotin status
timeFrame: after 24 weeks of intervention
measure: vitamin D status
timeFrame: after 24 weeks of intervention
measure: placental functional gene expression regulation
timeFrame: after 24 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brooklyn College of City University of New York
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References: