DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
N/A
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborators:
Abbott Northwestern Hospital Allina Health System Hartford Hospital
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamins