Hypertension, Pre-Hypertension, Vitamin D Deficiency
Conditions
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.
Interventions
DRUGCholecalciferol
Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily.
Sponsors
Hartford Hospital
Allina Health System
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure. | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed