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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Abbott Northwestern Hospital; Allina Health System; Hartford Hospital
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

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