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Completed

NCT Number: NCT01240512

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

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Key information

Conditions

Hypertension Avitaminosis Cardiovascular Diseases Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pre-Hypertension Prehypertension Vascular Diseases Vitamin D Deficiency

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital, Hartford, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Vitamin D3

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. Change in mean 24-hour ambulatory diastolic blood pressure

    Time frame: 24 hours

  2. Change in mean daytime and nighttime ambulatory systolic and diastolic blood pressure

    Time frame: 24 hours

  3. Change in mean clinic systolic and diastolic blood pressure

    Time frame: 6 months

  4. Change in mean clinic pulse pressure

    Time frame: 6 months

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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Allina Health System
  • Hartford Hospital

Registry information

Official study title

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

Acronym: DAYLIGHT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2010
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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