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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

534 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-10-31

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.

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Detailed Description

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Conditions

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Hypertension Vitamin D Deficiency Pre-Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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High Dose Arm

4000 IU/day Vitamin D3 (cholecalciferol) supplementation

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

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.

Low Dose Arm

400 IU/day Vitamin D3 (cholecalciferol) supplementation

Group Type ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type DRUG

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.

Interventions

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Cholecalciferol

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.

Intervention Type DRUG

Other Intervention Names

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Vitamin D3

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes