Clinical trial NCT01240512: DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Official title: Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Vitamin D Deficiency
Pre-Hypertension
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
name: Allina Health System
First posted: 2010-11-15
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.
timeFrame: 24 hours
Secondary outcomes:
measure: Change in mean 24-hour ambulatory diastolic blood pressure
timeFrame: 24 hours
measure: Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure
timeFrame: 24 hours
measure: Change in mean clinic systolic and diastolic blood pressure
timeFrame: 6 months
measure: Change in mean clinic pulse pressure
timeFrame: 6 months
measure: Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements
timeFrame: 6 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Massachusetts General Hospital
name: Thomas J Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.