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OpenTrials
Completed

NCT Number: NCT01166165

Effect of Vitamin D Replacement During Winter Months 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medical Research

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Cholecalciferol

Drug

3 tablets of 1000 IU daily for 20 weeks

Placebo

Drug

3 placebo tablets daily for 20 weeks

Primary outcomes

  1. 24-hour systolic blood pressure

    Time frame: 20 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Regional Hospital Holstebro

Other

Registry information

Official study title

Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 20, 2010
Registry last updated
Jun 19, 2012

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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