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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01166165
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : June 19, 2012
Information provided by (Responsible Party):
Erling Bjerregaard Pedersen, Regional Hospital Holstebro

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Vitamin D Deficiency Drug: Cholecalciferol Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
Study Start Date : July 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 24-hour systolic blood pressure [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Plasma renin concentration [ Time Frame: 20 weeks ]
  2. Plasma concentration of angiotensin II [ Time Frame: 20 weeks ]
  3. Plasma concentration of aldosterone [ Time Frame: 20 weeks ]
  4. Plasma concentration of c-reactive protein [ Time Frame: 20 weeks ]
  5. Urine albumin creatinine ratio [ Time Frame: 20 weeks ]
  6. Urine calcium creatinine ratio [ Time Frame: 20 weeks ]
  7. Plasma concentration of 25-hydroxycholecalciferol [ Time Frame: 5 weeks ]
  8. Serum concentration of FGF-23 [ Time Frame: 20 weeks ]
  9. Augmentation index and central blood pressure [ Time Frame: 20 weeks ]
  10. Pulse wave velocity [ Time Frame: 20 weeks ]
  11. Heart rate variability [ Time Frame: 20 weeks ]
  12. Plasma concentration of ionized calcium [ Time Frame: 5 weeks ]
  13. Plasma concentration of phosphate [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166165

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

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 ( Other Identifier: The Regional Committee on Biomedical Research Ethics )
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Erling Bjerregaard Pedersen, Regional Hospital Holstebro:
blood pressure
vitamin d
arterial stiffness

Additional relevant MeSH terms:
Vitamin D Deficiency
Vascular Diseases
Cardiovascular Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents