Prenatal Nutrient Status Study

October 7, 2024 updated by: Needed PBC

Baseline Nutritional Status During Pregnancy

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90049
        • Needed PBC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women who are currently pregnant who meet the inclusion and exclusion criteria will be eligible for participation in this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Needed PBC

Investigators

  • Principal Investigator: Ari Calhoun, ND, Wholesome Brain Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2023

Primary Completion (Actual)

August 24, 2024

Study Completion (Actual)

September 4, 2024

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ND.001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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