Prenatal Nutrient Status Study | NCT06156826

Studies
Prenatal Nutrient Status Study

NCT06156826

Sponsor

Needed PBC

Status

Completed

Last Update Posted

Oct 9, 2024Actual

Enrollment

502Actual

Phase

Not provided

Conditions

Pregnancy Related
Nutrient Deficiency

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2023Actual

Primary Completion Date

Aug 24, 2024Actual

Completion Date

Sep 4, 2024Actual

First Submitted Date

Nov 15, 2023

First Submission Date that Met QC Criteria

Dec 4, 2023

First Posted Date

Dec 5, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2024

Last Update Posted Date

Oct 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

502Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ari Calhoun, ND	Wholesome Brain Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Needed PBC		Los Angeles	California	90049	United States