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DAYLIGHT: Vitamin D Therapy in Individuals at High Risk of Hypertension | Clinical Trials | Clareo Health

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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

NCT01240512•Massachusetts General Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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
+9 more criteria

Locations (3)

Hartford Hospital

Hartford, Connecticut, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 1, 2010

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

March 9, 2017

Enrollment

534

ACTUAL participants

Conditions

HypertensionVitamin D DeficiencyPre-Hypertension

Interventions

Cholecalciferol

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

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