Vitamin D and Walking Ability in Patients With Peripheral Artery Occlusive Disease
Peripheral Arterial Disease
|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|
- 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.
- 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.
|Study Start Date:||November 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Vitamin D||
45'000 units of cholecalciferol per month for 3 months
|Placebo Comparator: Placebo||
Placebo to 45'000 units of Cholecalciferol per month for 3 months
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).
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.
- 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.
Prospective, randomised, double-blind, placebo-controlled, investigator-initiated pilot study with a study duration of 3 months and a 3 month - follow up.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559974
|Basel, Basel Stadt, Switzerland, 4031|
|Principal Investigator:||Kurt A Jaeger, Prof||University of Basel|