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

Mass General Brigham

Status

Completed

Conditions

Hypertension

Vitamin D Deficiency

Pre-Hypertension

Treatments

Drug: Cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT01240512

2010P001612

Details and patient eligibility

About

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.

Enrollment

534 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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