Hypertensive Disorders of PregnancyNCT07017920
Vitamin D and Hypertensive Disorders of Pregnancy
A study testing Vitamin D Levels measurement in people with Hypertensive Disorders of Pregnancy, run by TriHealth Inc..
Trial summary
The purpose of this study is to further investigate the association between vitamin D deficiency/insufficiency and hypertensive disorders of pregnancy by studying the impact of screening for vitamin D deficiency and supplementation when low levels of vitamin D are detected. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypertensive Disorders of Pregnancy
- What is being tested?
- Vitamin D Levels measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 594 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Pregnant women
- 18-45 years old
- Receiving care at outpatient OB office of TriHealth's Women's Services Comprehensive OB-GYN Team with a plan to deliver at Bethesda North Hospital
Who cannot join
- Non-English speaking
- Unable to provide consent to research study participation
- Diagnosis of preexisting renal disease
- Diagnoses of preexisting chronic hypertension
- Diagnosis of cardiovascular diseases
- Diagnosis of conditions limiting fat absorption
- Diagnosis of sarcoidosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Relationship Among Vitamin Deficiency/Insufficiency, Vitamin Supplementation, and Hypertensive Disorders of Pregnancy
The purpose of this study is to further investigate the association between vitamin D deficiency/insufficiency and hypertensive disorders of pregnancy by studying the impact of screening for vitamin D deficiency and supplementation when low levels of vitamin D are detected. Screening for vitamin D deficiency (less than 20 ng/mL) and insufficiency (less than 30 ng/mL) may determine the need for additional supplementation, as most prenatal vitamins only contain 400 IU of vitamin D. The rates of hypertensive disorders of pregnancy amongst patients who received supplementation and maintained adequate vitamin D levels will be followed.
- Conditions
- Hypertensive Disorders of Pregnancy
- Being tested
- Vitamin D Levels measurement
- Keywords
- vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D Levels measurementDiagnostic test
Patient will have a vitamin D level drawn with their other prenatal labs during an OB visit. If vitamin D insufficiency (less than 30 ng/mL) or deficiency (less than 20 ng/mL) is detected, the patient will be prescribed and provided a supplementation of 2000 IU of vitamin D daily for the remainder of the pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard OB care with no screening for vitamin D level. | No intervention | Patients will receive standard OB care with no screening for vitamin D level. |
| Arm 2: Vitamin D screening and supplementation if needed | Experimental | Patients will receive standard OB care and will have a vitamin D level drawn with their other prenatal labs during an OB visit. If vitamin D insufficiency (less than 30 ng/mL) or deficiency (less than 20 ng/mL) is detected, the patient will be prescribed and provided a supplementation of 2000 IU of vitamin D daily for the remainder of the pregnancy. Receives: Diagnostic Test: Vitamin D Levels measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertensive disorders of pregnancy
Was patient diagnosed with a hypertensive disorder of pregnancy (preeclampsia or GHTN) per clinician judgement based on ACOG guidelines
Measured: During pregnancy, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorders of PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 594 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017920
- Sponsor's protocol ID
- 24-073
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Among Vitamin Deficiency/Insufficiency, Vitamin Supplementation, and Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT07017920
- Acronym / sponsor ID
- 24-073
- Conditions
- Hypertensive Disorders of Pregnancy
- Keywords
- vitamin D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 594 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jun 2025 (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 study is to further investigate the association between vitamin D deficiency/insufficiency and hypertensive disorders of pregnancy by studying the impact of screening for vitamin D deficiency and supplementation when low levels of vitamin D are detected. Screening for vitamin D deficiency (less than 20 ng/mL) and insufficiency (less than 30 ng/mL) may determine the need for additional supplementation, as most prenatal vitamins only contain 400 IU of vitamin D. The rates of hypertensive disorders of pregnancy amongst patients who received supplementation and maintained adequate vitamin D levels will be followed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard OB care with no screening for vitamin D level. | No intervention | –Patients will receive standard OB care with no screening for vitamin D level. |
| Arm 2: Vitamin D screening and supplementation if needed | Experimental | Diagnostic Test: Vitamin D Levels measurementPatients will receive standard OB care and will have a vitamin D level drawn with their other prenatal labs during an OB visit. If vitamin D insufficiency (less than 30 ng/mL) or deficiency (less than 20 ng/mL) is detected, the patient will be prescribed and provided a supplementation of 2000 IU of vitamin D daily for the remainder of the pregnancy. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women
- 18-45 years old
- Receiving care at outpatient OB office of TriHealth's Women's Services Comprehensive OB-GYN Team with a plan to deliver at Bethesda North Hospital
Key exclusion criteria (7 listed)
- Non-English speaking
- Unable to provide consent to research study participation
- Diagnosis of preexisting renal disease
- Diagnoses of preexisting chronic hypertension
- Diagnosis of cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D Levels measurementPatient will have a vitamin D level drawn with their other prenatal labs during an OB visit. If vitamin D insufficiency (less than 30 ng/mL) or deficiency (less than 20 ng/mL) is detected, the patient will be prescribed and provided a supplementation of 2000 IU of vitamin D daily for the remainder of the pregnancy. | Diagnostic test | Arm 2: Vitamin D screening and supplementation if needed |
Primary outcome
Hypertensive disorders of pregnancy
Time frame: During pregnancy, up to 9 months
Was patient diagnosed with a hypertensive disorder of pregnancy (preeclampsia or GHTN) per clinician judgement based on ACOG guidelines
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D Levels measurement in people with Hypertensive Disorders of Pregnancy, run by TriHealth Inc..
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel B Baker (513-569-6191, Rachel_Baker2@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertensive disorders of pregnancy (time frame: During pregnancy, up to 9 months). 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 12 Jun 2025.