An interventional study of Cholecalciferol in Hypertension, Vitamin D Deficiency and Pre-Hypertension, sponsored by Massachusetts General Hospital. Completed at 3 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-09.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 534 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
4000 IU/day Vitamin D3 (cholecalciferol) supplementation
Drug: Cholecalciferol
400 IU/day Vitamin D3 (cholecalciferol) supplementation
Drug: Cholecalciferol
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.
Also known as: Vitamin D3
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital