Use of Ritual Prenatal Multivitamins for Pregnancy

City University of New York

Status: Enrolling

Conditions: Pregnancy Related; Nutrition, Healthy

Treatments: Dietary Supplement: control MVI; Dietary Supplement: Ritual Epre Multivitamin-mineral supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05673070

2022-0670-Brooklyn

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Ritual Epre

Experimental group

Description:

This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.

Treatment:

Dietary Supplement: Ritual Epre Multivitamin-mineral supplement

Control MVI

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: control MVI