DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension - Full Text View

Purpose

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	Intervention
Hypertension Vitamin D Deficiency Pre-Hypertension	Drug: Cholecalciferol


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in mean 24-hour ambulatory diastolic blood pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Change in mean clinic systolic and diastolic blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change in mean clinic pulse pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	534
Study Start Date:	December 2010
Study Completion Date:	October 2013
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Eligibility


Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240512

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

No publications provided


Responsible Party:	Thomas J. Wang, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01240512 History of Changes
Other Study ID Numbers:	2010P001612
Study First Received:	November 11, 2010
Last Updated:	November 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 27, 2015