CClinicalTrials.gg
CompletedNCT06156826Updated Oct 9, 2024

Prenatal Nutrient Status Study

An observational study in Pregnancy Related and Nutrient Deficiency, sponsored by Needed PBC. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-09.

Sponsored by Needed PBC · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
502
Ages
18 Years to 45 Years
Sex
Female
01

Study 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
02

Conditions studied

  • Pregnancy Related
  • Nutrient Deficiency
03

In context

Lead sponsor

This is the only study on the registry with Needed PBC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
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.

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

Exclusion Criteria:

  • Birth sex other than female
  • Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
502 participants (actual)
Patient registry
No
06

What researchers measure

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).

    Time frame: Baseline

07

Study locations

1 site
  • Needed PBC
    Los Angeles, California 90049, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06156826
Lead sponsor
Needed PBC
Responsible party
Sponsor
First posted
Dec 5, 2023
Start date
Nov 7, 2023
Primary completion
Aug 24, 2024
Completion
Sep 4, 2024
Last update
Oct 9, 2024

Study contacts

Ari Calhoun, ND
principal investigator · Wholesome Brain Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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