Vitamin D and Hypertensive Disorders of Pregnancy

TriHealth

Status: Not yet enrolling

Conditions: Hypertensive Disorders of Pregnancy

Treatments: Diagnostic Test: Vitamin D Levels measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT07017920

24-073

Details and patient eligibility

About

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.

Enrollment: 594 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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594 participants in 2 patient groups

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

No Intervention group

Description:

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

Arm 2: Vitamin D screening and supplementation if needed

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Vitamin D Levels measurement