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

Study Overview
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Brief Summary
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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.

Official Title
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Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension

Conditions
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Hypertension, Vitamin D Deficiency, Pre-Hypertension

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose Arm<br>4000 IU/day Vitamin D3 (cholecalciferol) supplementation | Drug: Cholecalciferol<br>* 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.<br>* Other names: Vitamin D3;|
| Active Comparator: Low Dose Arm<br>400 IU/day Vitamin D3 (cholecalciferol) supplementation | Drug: Cholecalciferol<br>* 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.<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |