Vitamin D and Hypertensive Disorders of Pregnancy
ConditionHypertensive Disorders of Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorTriHealth Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Non-English speaking
Unable to provide consent to research study participation
Diagnosis of preexisting renal disease
Diagnoses of preexisting chronic hypertension
Trial design
Design model
Single group
Treatments tested in this trial
Vitamin D Levels measurement
Diagnostic testPatient 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 groups
594 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Standard OB care with no screening for vitamin D level.No intervention 0 interventions
Group B: Arm 2: Vitamin D screening and supplementation if neededExperimental treatment 1 intervention
Trial outcomes
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: