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NCT06156826 Clinical Trial

Prenatal Nutrient Status Study

Pregnancy Related Clinical Trial

Official title:
Baseline Nutritional Status During Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06156826
Other study ID # ND.001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2023
Est. completion date May 1, 2024

Study information
Verified date December 2023
Source Needed PBC
Contact Study Coordinator
Phone 323-508-1542
Email research@thisisneeded.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research is to gather data on nutritional status from approximately 250 pregnant women who are currently taking a prenatal vitamin in order to better understand if the prenatal vitamins that most people use are providing enough nourishment during pregnancy. Participants will be asked to: - complete an online survey - schedule a blood draw for the Study Multivitamin Blood Test - complete the blood draw visit - complete a final survey at study end

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18 years of age or older - Speaks, reads, and understands English - Lives in the United States - Lives within a ZIP code from the metropolitan areas where mobile phlebotomists will be available for blood draws - Assigned female sex at birth - Currently within weeks 24-34 of pregnancy - Currently taking a daily prenatal vitamin Exclusion Criteria: - Birth sex other than female - Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Needed PBC Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
Needed PBC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of sample deficient in each nutrient in pregnant women Stratified by the type of prenatal vitamin they are taking at baseline (standard or Needed Prenatal Multivitamin). Baseline
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