Pregnancy RelatedNCT06156826
Prenatal Nutrient Status Study
An observational study of Pregnancy Related and Nutrient Deficiency, run by Needed PBC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy Related, Nutrient Deficiency
- How many people
- 502 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 4 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who are currently pregnant who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Who may be able to join
- 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
Who cannot join
- Birth sex other than female
- Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pregnancy Related, Nutrient Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start7 Nov 2023
- Primary completion24 Aug 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Needed PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ari Calhoun, ND, Principal investigator, Wholesome Brain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156826
- Sponsor's protocol ID
- ND.001
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Nutritional Status During Pregnancy
- ClinicalTrials.gov ID
- NCT06156826
- Acronym / sponsor ID
- ND.001
- Conditions
- Pregnancy Related, Nutrient Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Needed PBCIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who are currently pregnant who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Birth sex other than female
- Currently taking a prenatal vitamin without Folic Acid other than Needed Prenatal Multivitamin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Calhoun, ND principal investigator
Wholesome Brain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Nutrient Deficiency, run by Needed PBC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of sample deficient in each nutrient in pregnant women (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.