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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

November 11, 2010
November 7, 2013
December 2010
October 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01240512 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension
Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Hypertension
  • Vitamin D Deficiency
  • Pre-Hypertension
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: High Dose Arm
    4000 IU/day Vitamin D3 (cholecalciferol) supplementation
    Intervention: Drug: Cholecalciferol
  • Active Comparator: Low Dose Arm
    400 IU/day Vitamin D3 (cholecalciferol) supplementation
    Intervention: Drug: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
534
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240512
2010P001612
Yes
Thomas J. Wang, MD, Massachusetts General Hospital
Massachusetts General Hospital
  • Hartford Hospital
  • Abbott Northwestern Hospital
Principal Investigator: Thomas J Wang, MD Massachusetts General Hospital
Massachusetts General Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP