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

This study has been completed.
Sponsor:
Collaborators:
Hartford Hospital
Abbott Northwestern Hospital
Information provided by (Responsible Party):
Thomas J. Wang, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01240512
First received: November 11, 2010
Last updated: November 7, 2013
Last verified: November 2013
  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:


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

  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
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
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014