ClinicalTrials.gg
Not yet recruitingNCT07017920Updated Jun 12, 2025

Vitamin D and Hypertensive Disorders of Pregnancy

An interventional study of Vitamin D Levels measurement in Hypertensive Disorders of Pregnancy, sponsored by TriHealth Inc.. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by TriHealth Inc. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
594
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Hypertensive Disorders of Pregnancy

Keywords

  • vitamin D
03

In context

Lead sponsor

TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
594 participants (estimated)

Study arms

  • No intervention
    Arm 1: Standard OB care with no screening for vitamin D level.

    Patients will receive standard OB care with no screening for vitamin D level.

  • Experimental
    Arm 2: Vitamin D screening and supplementation if needed

    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.

    Diagnostic Test: Vitamin D Levels measurement

Interventions

  • Diagnostic testVitamin D Levels measurement

    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.

06

What researchers measure

Primary outcomes

  1. Hypertensive disorders of pregnancy

    Was patient diagnosed with a hypertensive disorder of pregnancy (preeclampsia or GHTN) per clinician judgement based on ACOG guidelines

    Time frame: During pregnancy, up to 9 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2025; primary completion for Jul 2027, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 4, 2025
First posted
Jun 12, 2025
StartEst.
Jul 1, 2025
Primary completionEst.
Jul 1, 2027
CompletionEst.
Dec 31, 2027
Last update
Jun 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07017920
Lead sponsor
TriHealth Inc.
Responsible party
Sponsor
First posted
Jun 12, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Jul 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jun 12, 2025

Study contacts

Rachel B Baker
Contact
Rachel_Baker2@trihealth.com
513-569-6191

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion