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Multivitamin-mineral supplement
Prenatal Multivitamins for Pregnancy
N/A
Recruiting
Research Sponsored by City University of New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pregnant women over 18 years of age
Be older than 18 years old
Must not have
Diabetes prior to and during pregnancy
Liver disease prior to and during pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 24 weeks of intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a prenatal multivitamin/multimineral supplement can improve nutrition status in pregnant women and their babies.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since both MVIs are commercially available and over-the-counter, side effects should be minimal but may include typical reactions such as nausea or digestive discomfort that some experience from taking vitamins.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant and over 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had diabetes before and during my pregnancy.
Select...
I have had liver disease before and during my pregnancy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 24 weeks of intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 24 weeks of intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Biotin status
Folate status
placental functional gene expression regulation
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ritual EpreExperimental Treatment1 Intervention
This group will receive 2 Ritual Epre multivitamin-mineral supplement pills daily.
Group II: Control MVIActive Control1 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.
Find a Location
Who is running the clinical trial?
City University of New YorkLead Sponsor
17 Previous Clinical Trials
5,706 Total Patients Enrolled
Maimonides Medical CenterOTHER
71 Previous Clinical Trials
15,440 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I am pregnant and over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Ritual Epre
- Group 2: Control MVI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.