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

December 1, 2011
March 8, 2013
November 2011
January 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01559974 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Vitamin D and Walking Ability in Patients With Peripheral Artery Occlusive Disease
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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Peripheral Arterial Disease
  • Drug: Placebo
    Placebo to 45'000 units of Cholecalciferol per month for 3 months
  • Drug: Cholecalciferol
    45'000 units of cholecalciferol per month for 3 months
  • Active Comparator: Vitamin D
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
February 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01559974
P Vit D 23032011 v2
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Kurt A Jaeger, Prof University of Basel
University Hospital, Basel, Switzerland
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP