Vitamin D and Walking Ability in Patients With Peripheral Artery Occlusive Disease

March 8, 2013 updated by: University Hospital, Basel, Switzerland

Phase 4 Study of 25-hydroxy-vitamin D in Patients With Peripheral Artery Occlusive Disease and Walking Ability

The purpose of this study is to determine whether the intake of Vitamin D has a positive effect on walking ability of patients with peripheral artery occlusive disease. Skeletal muscle fibers change morphology in peripheral artery occlusive disease. In patients with Vitamin D-deficiency there are also changes of skeletal muscle fibers. The investigators have the hypothesis that patients with peripheral artery occlusive disease with subsequent changes of muscle fibers morphology of calf muscles might take profit of the administration of Vitamin D in combination with training.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Background On the one hand, patients suffering from peripheral artery occlusive disease may have a significant decrease in their walking ability. When there is insufficient supply of oxygen to the muscles, especially the calf muscles, structural changes of skeletal muscle fibers appear. On the other hand, these patients might also have an insufficient supply with Vitamin D as it is often the case in the general population. A deficiency of Vitamin D also causes structural changes in the skeletal muscles and causes muscle weakness.

Hypothesis Vitamin D - intake can improve the walking ability of patients with peripheral artery occlusive disease and eventually Vitamin D - deficiency.

Aim of the study To evaluate the influence of Vitamin D - intake on walking ability of patients with peripheral artery occlusive disease, which would be a simple, safe and non-invasive measure with a positive effect on quality of life and indirectly on cardiovascular health in general (better mobility).

Primary endpoint:

Measurement of walking ability with treadmill test at the beginning and after a 3 month-treatment with Vitamin D, in combination with a home-based training.

Secondary endpoints:

  • Measurement of calf muscle perfusion as an indirect parameter for walking ability, measurement at the beginning, after three months and after a 6 month follow up.
  • Quality of life questionnaires (SF 36 and walking impairment questionnaire), visual analogue scale.

Study design:

Prospective, randomised, double-blind, placebo-controlled, investigator-initiated pilot study with a study duration of 3 months and a 3 month - follow up.

Study course:

6 study visits are planned.

  • Visit 0: screening visit, lab (Calcium, Vitamin D3), questionnaires
  • Visit 1: treadmill test, measurement of calf muscle perfusion, intake of first monthly dose of Cholecalciferol 45'000 units (or placebo)
  • Visit 2 (after 1 month): vital parameters, second dose of 45'000 units of Cholecalciferol (or placebo)
  • Visit 3 (after 2 months): vital parameters, third dose of 45'000 units of Cholecalciferol (or placebo)
  • Visit 4 (after 3 months): treadmill test, measurement of calf muscle perfusion , lab (Calcium, Vitamin D3), questionnaires
  • Visit 5 (after 6 months): treadmill test, measurement of calf muscle perfusion , lab (Calcium, Vitamin D3), questionnaires

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4031
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • peripheral artery obliterative disease Rutherford 1 to 3
  • informed consent
  • motivation

Exclusion Criteria:

  • inability of treadmill walking
  • not motivated
  • female patients: childbearing age (age limit 49 years)
  • PTA or surgical revascularisation within 3 months before study entry
  • cancer, life expectancy lower than 6 months
  • ongoing therapy with Vitamin D
  • 25-OH-Vitamin D level 125 nmol/l and above
  • contraindications for Vitamin D intake (sarcoidosis, acute lung tbc, hypercalcemia, intake of Vitamin D analogs
  • contraindications for ultrasound contrast agent (known hypersensitivity, recent acute coronary syndrome, unstable ischemic heart disease, after PTCA, heart insufficiency NYHA III or IV, severe rhythm disorders, known right- left shunt, severe pulmonary artery hypertension, adult respiratory distress syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo to 45'000 units of Cholecalciferol per month for 3 months
ACTIVE_COMPARATOR: Vitamin D
Drug: Cholecalciferol
45'000 units of cholecalciferol per month for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline initial claudication distance (ICD) at 3 months
Time Frame: 3 months
Follow up after 6 months.
3 months
Change from baseline absolute claudication distance (ACD) at 3 months
Time Frame: 3 months
Follow up after 6 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Vitamin D3 at 3 months
Time Frame: 3 months
Follow up after 6 months.
3 months
Change of baseline Calcium at 3 months
Time Frame: 3 months
Follow up after 6 months.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Kurt A Jaeger, Prof, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

December 1, 2011

First Submitted That Met QC Criteria

March 19, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 8, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P Vit D 23032011 v2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peripheral Arterial Disease

Clinical Trials on Cholecalciferol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe