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Styrian Vitamin D Hypertension Trial

NCT02136771 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-11-25

No results posted yet for this study

Summary

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.

Conditions

  • Arterial Hypertension
  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D3

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

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Stefan Pilz, MD, PhD · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02136771 on ClinicalTrials.gov