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

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01559974
First received: December 1, 2011
Last updated: March 8, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
 Drug: Placebo
Drug: Cholecalciferol
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4 Study of 25-hydroxy-vitamin D in Patients With Peripheral Artery Occlusive Disease and Walking Ability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Change from baseline initial claudication distance (ICD) at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Follow up after 6 months.

  • Change from baseline absolute claudication distance (ACD) at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Follow up after 6 months.


Secondary Outcome Measures:
  • Change from baseline Vitamin D3 at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Follow up after 6 months.

  • Change of baseline Calcium at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Follow up after 6 months.


Enrollment: 4
Study Start Date: November 2011
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D Drug: Cholecalciferol
45'000 units of cholecalciferol per month for 3 months
Placebo Comparator: Placebo Drug: Placebo
Placebo to 45'000 units of Cholecalciferol per month for 3 months

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559974

Locations
Switzerland
University Hospital
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Kurt A Jaeger, Prof University of Basel
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01559974     History of Changes
Other Study ID Numbers: P Vit D 23032011 v2
Study First Received: December 1, 2011
Last Updated: March 8, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Peripheral arterial disease
PAOD
Vitamin D
Walking impairment

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cholecalciferol
 Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 18, 2013