DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension (DAYLIGHT)
Primary Purpose
Hypertension, Vitamin D Deficiency, Pre-Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
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
Sites / Locations
- Hartford Hospital
- Massachusetts General Hospital
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High Dose Arm
Low Dose Arm
Arm Description
4000 IU/day Vitamin D3 (cholecalciferol) supplementation
400 IU/day Vitamin D3 (cholecalciferol) supplementation
Outcomes
Primary Outcome Measures
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
Secondary Outcome Measures
Change in mean 24-hour ambulatory diastolic blood pressure
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Change in mean clinic systolic and diastolic blood pressure
Change in mean clinic pulse pressure
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Full Information
NCT ID
NCT01240512
First Posted
November 11, 2010
Last Updated
March 8, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Hartford Hospital, Allina Health System
1. Study Identification
Unique Protocol Identification Number
NCT01240512
Brief Title
DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Acronym
DAYLIGHT
Official Title
Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Hartford Hospital, Allina Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vitamin D Deficiency, Pre-Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
534 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Arm
Arm Type
Active Comparator
Arm Description
4000 IU/day Vitamin D3 (cholecalciferol) supplementation
Arm Title
Low Dose Arm
Arm Type
Active Comparator
Arm Description
400 IU/day Vitamin D3 (cholecalciferol) supplementation
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Vitamin D3
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in mean 24-hour ambulatory diastolic blood pressure
Time Frame
24 hours
Title
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
Time Frame
24 hours
Title
Change in mean clinic systolic and diastolic blood pressure
Time Frame
6 months
Title
Change in mean clinic pulse pressure
Time Frame
6 months
Title
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Wang, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33960201
Citation
Miao J, Bachmann KN, Huang S, Su YR, Dusek J, Newton-Cheh C, Arora P, Wang TJ. Effects of Vitamin D Supplementation on Cardiovascular and Glycemic Biomarkers. J Am Heart Assoc. 2021 May 18;10(10):e017727. doi: 10.1161/JAHA.120.017727. Epub 2021 May 7.
Results Reference
derived
PubMed Identifier
26451070
Citation
Zaleski A, Panza G, Swales H, Arora P, Newton-Cheh C, Wang T, Thompson PD, Taylor B. High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency. Dis Markers. 2015;2015:918968. doi: 10.1155/2015/918968. Epub 2015 Sep 16.
Results Reference
derived
PubMed Identifier
25359163
Citation
Arora P, Song Y, Dusek J, Plotnikoff G, Sabatine MS, Cheng S, Valcour A, Swales H, Taylor B, Carney E, Guanaga D, Young JR, Karol C, Torre M, Azzahir A, Strachan SM, O'Neill DC, Wolf M, Harrell F, Newton-Cheh C, Wang TJ. Vitamin D therapy in individuals with prehypertension or hypertension: the DAYLIGHT trial. Circulation. 2015 Jan 20;131(3):254-62. doi: 10.1161/CIRCULATIONAHA.114.011732. Epub 2014 Oct 30.
Results Reference
derived
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DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
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