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Completed

NCT Number: NCT02136771

Styrian Vitamin D Hypertension Trial

In this randomized, double-blind, placebo-controlled trial we plan to enrol 200 vitamin D deficient hypertensive patients. Our main objective is to evaluate whether vitamin D3 supplementation with 2,800 IU daily for 8 weeks has an effect on 24-hour systolic ambulatory blood pressure (ABP) compared to placebo. In addition, we also aim to evaluate whether vitamin D3 supplementation alters 24-hour diastolic ABP, pulse wave velocity, N-terminal-pro-brain natriuretic peptide (NT-pro-BNP), corrected QT interval (Bazett formula), renin, aldosterone, 24-hour urinary albumin excretion, HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance), triglycerides and HDL-cholesterol.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 25-hydroxyvitamin D levels below 30 ng/ml (75 nmol/L)
  • Arterial hypertension defined according to recent guidelines as an average office blood pressure on at least two occasions of systolic ≥ 140 and/or diastolic ≥ 90 mmHg or a mean 24-hour ABP of systolic ≥ 125 and/or diastolic ≥ 80, or a home blood pressure of systolic ≥ 130 and/or diastolic ≥ 85 or ongoing antihypertensive treatment which was initiated due to arterial hypertension
  • Age of ≥ 18 years
  • Written informed consent.

Exclusion criteria

  • Hypercalcemia defined a serum calcium >2.65 mmol/L
  • Pregnancy or lactating women
  • Drug intake as part of another clinical study
  • Acute coronary syndrome or cerebrovascular events in the previous 2 weeks
  • Glomerular filtration rate (GFR) according to the MDRD formula < 15 ml/min/1.73m²
  • Systolic 24-hour ABP > 160 mm Hg or < 120 mm Hg
  • Diastolic 24-hour ABP > 100 mm Hg
  • Change of antihypertensive treatment (drugs and/or lifestyle) in the previous 4 weeks or planned changes of antihypertensive treatment during the study
  • Any disease with an estimated life expectancy below 1 year
  • Any clinically significant acute disease requiring drug treatment
  • Chemotherapy or radiation therapy during the study
  • Regular intake of more than 880 International Units (IU) vitamin D per day in the last four weeks before study entry or during the study

Treatment and study plan

Vitamin D3

Dietary Supplement

The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks

Placebo

Dietary Supplement

Primary outcomes

  1. 24-hour systolic ambulatory blood pressure

    Time frame: 8 weeks

Secondary outcomes

  1. 24-hour diastolic ambulatory blood pressure

    Time frame: 8 weeks

  2. N-terminal-pro-brain natriuretic peptide (NT-pro-BNP)

    Time frame: 8 weeks

  3. corrected QT interval (Bazett formula)

    Time frame: 8 weeks

  4. Renin

    Time frame: 8 weeks

    Plasma renin concentration

  5. Aldosterone

    Time frame: 8 weeks

    Plasma aldosterone concentration

  6. 24-hour urinary albumin excretion

    Time frame: 8 weeks

  7. HOMA-IR

    Time frame: 8 weeks

    HOMA-IR (HOmeostatic Model Assessment: Insulin Resistance)

  8. Triglycerides

    Time frame: 8 weeks

  9. HDL-cholesterol

    Time frame: 8 weeks

  10. Pulse wave velocity

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Styrian Vitamin D Hypertension Trial: A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Effects of Vitamin D Supplementation on Systolic Ambulatory Blood Pressure in Vitamin D Deficient Hypertensive Patients

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 13, 2014
Registry last updated
Nov 25, 2014

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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