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

NCT01240512 | Completed DMC

• 1 other identifier: 2010P001612
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hypertension; Vitamin D Deficiency; Pre-Hypertension

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is defined as the change in mean 24-hour ambulatory systolic blood pressure.

  24 hours

Secondary Outcomes (5)

• Change in mean 24-hour ambulatory diastolic blood pressure

  24 hours

• Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure

  24 hours

• Change in mean clinic systolic and diastolic blood pressure

  6 months

• Change in mean clinic pulse pressure

  6 months

• Relation of vitamin D status to changes in clinic and 24-hour ambulatory blood pressure measurements

  6 months

Study Arms (2)

High Dose Arm

ACTIVE COMPARATOR

4000 IU/day Vitamin D3 (cholecalciferol) supplementation

Drug: Cholecalciferol

Low Dose Arm

ACTIVE COMPARATOR

400 IU/day Vitamin D3 (cholecalciferol) supplementation

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

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.

Also known as: Vitamin D3

High Dose Arm; Low Dose Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Hartford Hospital: collaborator
• Allina Health System: collaborator

Study Sites (3)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (3)

• Miao J, Bachmann KN, Huang S, Su YR, Dusek J, Newton-Cheh C, Arora P, Wang TJ. Effects of Vitamin D Supplementation on Cardiovascular and Glycemic Biomarkers. J Am Heart Assoc. 2021 May 18;10(10):e017727. doi: 10.1161/JAHA.120.017727. Epub 2021 May 7.

  PMID: 33960201 DERIVED

• Zaleski A, Panza G, Swales H, Arora P, Newton-Cheh C, Wang T, Thompson PD, Taylor B. High-Dose versus Low-Dose Vitamin D Supplementation and Arterial Stiffness among Individuals with Prehypertension and Vitamin D Deficiency. Dis Markers. 2015;2015:918968. doi: 10.1155/2015/918968. Epub 2015 Sep 16.

  PMID: 26451070 DERIVED

• Arora P, Song Y, Dusek J, Plotnikoff G, Sabatine MS, Cheng S, Valcour A, Swales H, Taylor B, Carney E, Guanaga D, Young JR, Karol C, Torre M, Azzahir A, Strachan SM, O'Neill DC, Wolf M, Harrell F, Newton-Cheh C, Wang TJ. Vitamin D therapy in individuals with prehypertension or hypertension: the DAYLIGHT trial. Circulation. 2015 Jan 20;131(3):254-62. doi: 10.1161/CIRCULATIONAHA.114.011732. Epub 2014 Oct 30.

  PMID: 25359163 DERIVED

MeSH Terms

Conditions

Hypertension; Vitamin D Deficiency; Prehypertension

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Thomas J Wang, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

US (3)