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Prenatal Nutrient Status Study

Sponsor
Needed PBC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06156826
Collaborator
(none)
250
Enrollment
1
Location
5.8
Anticipated Duration (Months)
43.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Baseline Nutritional Status During Pregnancy
    Actual Study Start Date :
    Nov 7, 2023
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    May 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of sample deficient in each nutrient in pregnant women [Baseline]

      Stratified by the type of prenatal vitamin they are taking at baseline (standard or Needed Prenatal Multivitamin).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Needed PBC Los Angeles California United States 90049

    Sponsors and Collaborators

    • Needed PBC

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Needed PBC
    ClinicalTrials.gov Identifier:
    NCT06156826
    Other Study ID Numbers:
    • ND.001
    First Posted:
    Dec 5, 2023
    Last Update Posted:
    Dec 5, 2023
    Last Verified:
    Dec 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 5, 2023