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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01559974
• Other study ID #: P Vit D 23032011 v2
• Status: Terminated
• Phase: Phase 4
• First received: December 1, 2011
• Last updated: March 8, 2013
• Start date: November 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Placebo
Placebo to 45'000 units of Cholecalciferol per month for 3 months
• Cholecalciferol
45'000 units of cholecalciferol per month for 3 months

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline initial claudication distance (ICD) at 3 months	Follow up after 6 months.	3 months	No
Primary	Change from baseline absolute claudication distance (ACD) at 3 months	Follow up after 6 months.	3 months	No
Secondary	Change from baseline Vitamin D3 at 3 months	Follow up after 6 months.	3 months	Yes
Secondary	Change of baseline Calcium at 3 months	Follow up after 6 months.	3 months	Yes