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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Vitamin D Deficiency; Pre-Hypertension	Drug: Cholecalciferol	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	534 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension
Study Start Date :	December 2010
Actual Primary Completion Date :	October 2013
Actual Study Completion Date :	October 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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 Name: Vitamin D3

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Change in mean 24-hour ambulatory diastolic blood pressure [ Time Frame: 24 hours ]
2. Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure [ Time Frame: 24 hours ]
3. Change in mean clinic systolic and diastolic blood pressure [ Time Frame: 6 months ]
4. Change in mean clinic pulse pressure [ Time Frame: 6 months ]
5. Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Hartford Hospital

Abbott Northwestern Hospital

Investigators

Principal Investigator:	Thomas J Wang, MD	Massachusetts General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Thomas J. Wang, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01240512 History of Changes
Other Study ID Numbers:	2010P001612
First Posted:	November 15, 2010
Last Update Posted:	March 9, 2017
Last Verified:	March 2017

Additional relevant MeSH terms:

Hypertension; Vitamin D Deficiency; Prehypertension; Vascular Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders	Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents