The Relationship Among Vitamin Deficiency/Insufficiency, Vitamin Supplementation, and Hypertensive Disorders of Pregnancy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- TriHealth Inc.
- Enrollment
- 594
- Primary Endpoint
- Hypertensive disorders of pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Vitamin D Levels measurement (Diagnostic Test)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported