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

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Other Indications, Gastrointestinal
Therapuetic Areas:	Cardiology / Vascular Diseases, Gastroenterology, Other
Healthy:	No
Age Range:	18 - 50
Updated:	3/10/2017
Start Date:	December 2010
End Date:	October 2013

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.

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

We found this trial at

sites

Massachusetts General Hospital

185 Cambridge Street
Boston, Massachusetts 02114

617-724-5200