DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Completed · Not applicable
Conditions studied: Hypertension, Vitamin D Deficiency, Pre-Hypertension
In brief
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.
Key facts
- Study ID
- NCT01240512
- Run by
- Massachusetts General Hospital
- People needed
- 534
- Starts
- 2010-12-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2017-03-09
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hartford Hospital — Hartford, Connecticut, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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