NCT06156826

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

November 15, 2023

Last Update Submit

October 7, 2024

Conditions

Pregnancy RelatedNutrient Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Birth sex other than female
  • Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Needed PBC

Los Angeles, California, 90049, United States

Location

Study Officials

  • Ari Calhoun, ND

    Wholesome Brain Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

December 5, 2023

Study Start

November 7, 2023

Primary Completion

August 24, 2024

Study Completion

September 4, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

US(1)