DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension

Not Applicable

Completed

Conditions: Vitamin D Deficiency
Pre-Hypertension
Hypertension

Interventions: Drug: Cholecalciferol

Registration Number: NCT01240512

Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 534

Inclusion Criteria

Males or females 18 to 50 years of age
Systolic blood pressure of 120 to 159 mmHg and Diastolic blood pressure ≤99 mmHg
Vitamin D deficiency, defined as 25-hydroxyvitamin D <25 ng/ml
No use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
No use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months

Exclusion Criteria

Use of any anti-hypertensive medication in last 3 months or anticipated or planned use in next 6 months
Use of vitamin D supplementation in last 3 months, defined as vitamin D found in a multivitamin or supplement totaling >400 IU per day or anticipated or planned use in next 6 months
Use of St. John's wart, rifampin, any treatment for HIV, orlistat, oral glucocorticoids, phenobarbital, phenytoin, mineral oil, or bile acid sequestrants in the last 3 months or anticipated or planned use in next 6 months
Female who is pregnant, nursing, or of childbearing potential and planning or anticipating pregnancy in next 6 months
History of diabetes mellitus (including Type 1, Type 2 and diet controlled)
Serum creatinine >2.0 mg/dl or estimated Glomerular Filtration Rate (GFR) <30 ml/min
Calcium >10.0 mg/dl or phosphorus >5 mg/dl
History of kidney stones
Body mass index >38 kg/m2
Known cardiovascular disease: defined as prior myocardial infarction, percutaneous transluminal coronary angioplasty, coronary artery bypass or stroke
History of cirrhosis or severe liver disease (defined as history of GI bleeding from liver disease, jaundice or ascites)
Current heavy alcohol use: defined as drinking 5 or more drinks per occasion on 5 or more days in the past 30 days
History of ulcerative colitis, Crohn's disease, celiac disease, colostomy, pancreatic enzyme deficiency, short bowel syndrome, gastric bypass, cystic fibrosis, or dumping syndrome.
Allergy to coconut
Regular use or planned use of artificial tanning lights in next 6 months
Use of any investigational product or device in last 3 months or planned use in next 6 months
Any condition which could limit the ability to complete and comply with 6-month follow up
Unwillingness or inability to comply with study requirements
Inability to provide informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Arm	Cholecalciferol	4000 IU/day Vitamin D3 (cholecalciferol) supplementation
Low Dose Arm	Cholecalciferol	400 IU/day Vitamin D3 (cholecalciferol) supplementation

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.	24 hours

Secondary Outcome Measures

Name	Time	Method
Change in mean 24-hour ambulatory diastolic blood pressure	24 hours
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure	24 hours
Change in mean clinic systolic and diastolic blood pressure	6 months
Change in mean clinic pulse pressure	6 months
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements	6 months

Trial Locations

Locations (3): Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States