This is a randomized, double-blind, multicenter, 6-month follow-up trial of low (400 IU/day) versus high (4000 IU/day) dose vitamin D supplementation in individuals with pre- and early stage 1 hypertension and vitamin D deficiency. A total of 530 participants (265 participants per treatment arm) will be randomized between 3 sites. Approximately 2,250 participants will be screened between the 3 sites. Vital signs, 24-hour ambulatory blood pressure monitoring, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the effectiveness of the two doses of vitamin D on blood pressure. Blood samples will be stored for future biomarker assessments. The total duration of the study is anticipated to be 18 months, assuming a 12 month enrollment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
534
Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily.
Hartford Hospital
Hartford, Connecticut, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
Time frame: 24 hours
Change in mean 24-hour ambulatory diastolic blood pressure
Time frame: 24 hours
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Time frame: 24 hours
Change in mean clinic systolic and diastolic blood pressure
Time frame: 6 months
Change in mean clinic pulse pressure
Time frame: 6 months
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Time frame: 6 months
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