Clinical trial NCT03615833: Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: peripheral artery disease
Vitamin D
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2018-08-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 )

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

Primary outcomes:
measure: Change of the maximum walking distance on treadmill
timeFrame: baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)
timeFrame: 24 weeks
measure: Compliance with Vitamin D supplementation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital, Angers
name: Samir Henni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: