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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014