Prenatal Multivitamins for Pregnancy

Recruiting at 1 trial location

Overseen By Xinyin Jiang, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City University of New York

Disqualifiers: Diabetes, Cardiovascular, Liver disease

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for pregnant women over 18 with a single baby, who are not dealing with diabetes, heart conditions, or liver disease before or during pregnancy. It's designed to help those interested in optimizing their nutrition and the health of their unborn child.

Inclusion Criteria

Pregnant women with singleton pregnancy

Pregnant women without any conditions listed in the exclusion criteria

I am pregnant and over 18 years old.

Exclusion Criteria

I have had diabetes before and during my pregnancy.

I have had heart conditions before and during my pregnancy.

I have had liver disease before and during my pregnancy.

Treatment Details

Interventions

• control MVI
• Placebo control
• Ritual Epre Multivitamin-mineral supplement

Trial Overview The study compares two prenatal multivitamins: Ritual Epre Multivitamin-mineral supplement and a control MVI. Participants will be randomly assigned to one of these groups and take the supplements throughout their pregnancy to see which leads to better maternal-fetal nutrition.

Participant Groups

Group I: Ritual Epre Experimental Treatment 1 Intervention

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

Group II: Control MVI Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

City University of New York

Lead Sponsor

Trials

23

Recruited

6,000+

Maimonides Medical Center

Collaborator

Trials

72

Recruited

15,400+