Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01166165
First received: July 19, 2010
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.


Condition Intervention Phase
Hypertension
Vitamin D Deficiency
Drug: Cholecalciferol
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • 24-hour systolic blood pressure [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma renin concentration [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of angiotensin II [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of aldosterone [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of c-reactive protein [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Urine albumin creatinine ratio [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Urine calcium creatinine ratio [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of 25-hydroxycholecalciferol [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Serum concentration of FGF-23 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Augmentation index and central blood pressure [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Heart rate variability [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Plasma concentration of ionized calcium [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
  • Plasma concentration of phosphate [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 136
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cholecalciferol Drug: Cholecalciferol
3 tablets of 1000 IU daily for 20 weeks
Placebo Comparator: Placebo Drug: Placebo
3 placebo tablets daily for 20 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Well-regulated arterial hypertension
  • Office blood pressure > 120/70 mmHg

Exclusion Criteria:

  • Pregnancy or nursing
  • Cancer
  • Alcohol abuse
  • Continuous glucocorticoid or NSAID treatment
  • 24-hour blood pressure > 150/95 mmHg
  • Hypercalcemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166165

Locations
Denmark
Department of Medical Research
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Principal Investigator: Thomas Larsen, M.D. Departments of Medical Research, Holstebro Hospital
  More Information

No publications provided by Regional Hospital Holstebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erling Bjerregaard Pedersen, DMSci, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT01166165     History of Changes
Other Study ID Numbers: EBP-TL-2010-2, M-20100120
Study First Received: July 19, 2010
Last Updated: June 18, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
Hypertension
blood pressure
vitamin d
winter
cholecalciferol
arterial stiffness
renin
angiotensin
aldosterone
calcium

Additional relevant MeSH terms:
Hypertension
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 17, 2014