Clinical trial NCT01559974: Vitamin D and Walking Ability in Patients With Peripheral Artery Occlusive Disease
Official title: Phase 4 Study of 25-hydroxy-vitamin D in Patients With Peripheral Artery Occlusive Disease and Walking Ability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
PAOD
Vitamin D
Walking impairment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change from baseline initial claudication distance (ICD) at 3 months
timeFrame: 3 months
measure: Change from baseline absolute claudication distance (ACD) at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline Vitamin D3 at 3 months
timeFrame: 3 months
measure: Change of baseline Calcium at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: Basel Stadt
Study officials:
affiliation: University of Basel
name: Kurt A Jaeger, Prof
role: PRINCIPAL_INVESTIGATOR
References: