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

Hypertension Clinical Trial

— DAYLIGHT  

Official title:

Daylight: The Effect of Vitamin D Supplementation on Blood Pressure in Vitamin D Deficient Individuals With Pre-Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240512
• Other study ID #: 2010P001612
• Status: Completed
• Phase: N/A
• First received: November 11, 2010
• Last updated: March 8, 2017
• Start date: December 2010
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pre-Hypertension
• Prehypertension
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Hartford Hospital	Hartford	Connecticut
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Abbott Northwestern Hospital, Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.		24 hours
Secondary	Change in mean 24-hour ambulatory diastolic blood pressure		24 hours
Secondary	Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure		24 hours
Secondary	Change in mean clinic systolic and diastolic blood pressure		6 months
Secondary	Change in mean clinic pulse pressure		6 months
Secondary	Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements		6 months