Use of Ritual Prenatal Multivitamins for Pregnancy

Pregnancy Related Clinical Trial

Official title:

Use of Ritual Prenatal Multivitamins to Improve Nutrition Status and Health Outcomes During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673070
• Other study ID #: 2022-0670-Brooklyn
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: City University of New York
• Contact: Xinyin Jiang, PhD
• Phone: 7189515000
• Email: XinyinJiang[@]brooklyn.cuny.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Dietary Supplement:
• Ritual Epre Multivitamin-mineral supplement
The Ritual Epre supplement uses methyl folate instead of folic acid and has higher vitamin D and biotin contents compared to the control supplement.
• control MVI
The control MVI supplement is a commercially available product from another brand. Since this MVI doesn't contain DHA, a pill of DHA will also be provided to participants in this group.

Locations

Country	Name	City	State
United States	Brooklyn College of City University of New York	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
City University of New York	Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Folate status	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.	after 24 weeks of intervention
Primary	Biotin status	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.	after 24 weeks of intervention
Primary	vitamin D status	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.	after 24 weeks of intervention
Primary	placental functional gene expression regulation	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.	after 24 weeks of intervention