Vitamin D and Hypertensive Disorders of Pregnancy

NCT ID: NCT07017920

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 594 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Vitamin D Levels measurement

Intervention Type: 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.

Interventions

Vitamin 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rachel B Baker

Role: CONTACT

Rachel_Baker2@trihealth.com

513-569-6191

Other Identifiers

24-073

Identifier Type: -

Identifier Source: org_study_id