Vitamin D and Hypertensive Disorders of Pregnancy

NCT07017920 | Not Yet Recruiting DMC

• 1 other identifier: 24-073
• Study Type: interventional
• Target: 594
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertensive Disorders of Pregnancy

Keywords

vitamin D

Outcome Measures

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

  During pregnancy, up to 9 months

Study Arms (2)

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.

Diagnostic Test: Vitamin D Levels measurement

Interventions

Vitamin D Levels measurement DIAGNOSTIC_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.

Arm 2: Vitamin D screening and supplementation if needed

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Central Study Contacts

Rachel B Baker

CONTACT

513-569-6191; Rachel_Baker2@trihealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06