Evaluation of a Strategy for Systematic Screening for Vitamin D Deficiency and Treatment in Case of Deficiency, on the Improvement of the Maximum Walking Distance in Patients With Stage 2 Lower Limb Arterial Disease.
Overview
- Phase
- Phase 4
- Intervention
- Cholecalciferol
- Conditions
- Peripheral Arterial Disease
- Sponsor
- University Hospital, Angers
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change of the maximum walking distance on treadmill
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The prevalence of peripheral arterial disease (PAD) is greater than 15%. PAD is associated with an increased risk of cardiovascular death, coronary heart disease and stroke, with a mortality rate of 5% per year.
Most clinical evidence supports the idea that having normal vitamin D reduces cardiovascular risk. The data suggests that normalizing vitamin D levels would have a significant impact on public health, reduce costs and help control the incidence and prevalence of cardiovascular disease.
There is also a plausible physiological theory, supported by numerous observational studies, that vitamin D supplementation should be effective in improving cardiovascular outcomes, such as blood pressure, arterial stiffness, atherosclerosis, endothelial function, and clinical events.
The investigators hypothesize that routine screening for vitamin D deficiency and supplementation in case of hypovitaminosis D is effective for improving the maximum walking distance after 12 weeks of treatment in stage 2 PAD patients .
Detailed Description
At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. Vitamin D level will be assessed : Patients without vitamin D deficiency will be excluded. The influence of vitamin D supplementation on the evolution of walking distance in 12 weeks will be studied by comparing the spontaneous evolution of this walking distance, in not supplemented patients (period 1 ), and the evolution under treatment with vitamin D (period 2, afer 3 months ). The spontaneous evolution of the walking distance will be evaluated by the difference in walking distance observed between the beginning and the end of the first Period (3 months) . The evolution of walking distance under vitamin D treatment will be evaluated by the difference in walking distance between between the beginning and the end of the second Period (3 months). The duration of participation for a subject is equal to 6 months (2 periods of 3 months )
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients presenting a Peripheral Arterial Disease (Stage 2)
- •Affiliation to the French National healthcare system
- •French speaking patients
Exclusion Criteria
- •Pregnancy
- •Inability to understand the study goal
- •Patients protected by decision of law
Arms & Interventions
Patients with Vitamin D deficiency
Patients with Vitamin D deficiency, Administration of Cholecalciferol 2.5 mg (100 000 UI), once a month for 3 months
Intervention: Cholecalciferol
Outcomes
Primary Outcomes
Change of the maximum walking distance on treadmill
Time Frame: baseline, 12 weeks and 24 weeks
the Walking distance will be assessed during a test on a treadmill according to a standardized procedure
Secondary Outcomes
- Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)(24 weeks)
- Compliance with Vitamin D supplementation(24 weeks)