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

NCT01559974 | Terminated Phase 4 DMC

• 1 other identifier: P Vit D 23032011 v2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease; PAOD; Vitamin D; Walking impairment

Outcome Measures

Primary Outcomes (2)

• Change from baseline initial claudication distance (ICD) at 3 months

  Follow up after 6 months.

  3 months

• Change from baseline absolute claudication distance (ACD) at 3 months

  Follow up after 6 months.

  3 months

Secondary Outcomes (2)

• Change from baseline Vitamin D3 at 3 months

  3 months

• Change of baseline Calcium at 3 months

  3 months

Study Arms (2)

Vitamin D

ACTIVE COMPARATOR

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Placebo to 45'000 units of Cholecalciferol per month for 3 months

Placebo

Cholecalciferol DRUG

45'000 units of cholecalciferol per month for 3 months

Vitamin D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• peripheral artery obliterative disease Rutherford 1 to 3
• informed consent
• motivation

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kurt A Jaeger, Prof

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: March 21, 2012
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 11, 2013

Record last verified: 2013-03

Locations

CH (1)