Status:
COMPLETED
DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Hartford Hospital
Allina Health System
Conditions:
Hypertension
Vitamin D Deficiency
Eligibility:
All Genders
18-50 years
Phase:
NA
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 hyperte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
534 Patients enrolled
Trial Details
Trial ID
NCT01240512
Start Date
December 1 2010
End Date
October 1 2013
Last Update
March 9 2017
Active Locations (3)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407