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

March 8, 2017 updated by: Thomas J. Wang, MD, Massachusetts General Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Dose Arm
4000 IU/day Vitamin D3 (cholecalciferol) supplementation
Drug: 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.
Other Names:
  • Vitamin D3
Active Comparator: Low Dose Arm
400 IU/day Vitamin D3 (cholecalciferol) supplementation
Drug: 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.
Other Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean 24-hour ambulatory diastolic blood pressure
Time Frame: 24 hours
24 hours
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Time Frame: 24 hours
24 hours
Change in mean clinic systolic and diastolic blood pressure
Time Frame: 6 months
6 months
Change in mean clinic pulse pressure
Time Frame: 6 months
6 months
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Hartford Hospital
Allina Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 11, 2010

First Submitted That Met QC Criteria

November 11, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Actual)

March 9, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010P001612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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