Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking

Peripheral Arterial Disease Clinical Trial

— First-BLINDOS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615833
• Other study ID #: 2018-004146-41
• Status: Completed
• Phase: Phase 4
• Start date: March 11, 2019
• Est. completion date: September 21, 2020

Study information

• Verified date: September 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• Cholecalciferol
Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months

Locations

Country	Name	City	State
France	CHU Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the maximum walking distance on treadmill	the Walking distance will be assessed during a test on a treadmill according to a standardized procedure	baseline, 12 weeks and 24 weeks
Secondary	Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)	Prevalence and description of adverse events reported by the patient in a patient book and data collected at the end of treatment	24 weeks
Secondary	Compliance with Vitamin D supplementation	Recording of vitamin D intake by the patient in a patient booklet and counting of the number of vitamin D boxes in the V2 visit	24 weeks