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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
History of Changes

July 19, 2010
June 18, 2012
July 2010
April 2011   (final data collection date for primary outcome measure)
24-hour systolic blood pressure [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01166165 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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-hydroxy cholecaliferol [ 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 ]
Not Provided
Not Provided
 
Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension
Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • Vitamin D Deficiency
  • Drug: Cholecalciferol
    3 tablets of 1000 IU daily for 20 weeks
  • Drug: Placebo
    3 placebo tablets daily for 20 weeks
  • Active Comparator: Cholecalciferol
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01166165
EBP-TL-2010-2, M-20100120
Yes
Erling Bjerregaard Pedersen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Thomas Larsen, M.D. Departments of Medical Research, Holstebro Hospital
Regional Hospital Holstebro
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP