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

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT03615833
• Lead Sponsor: University Hospital, Angers

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 )

Study Timeline

• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-06
• Study Start: 2019-03-11
• Status Verified: 2020-09
• Primary Completion: 2020-09-21
• Study Completion: 2020-09-21
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Vitamin D deficiency	Cholecalciferol	Patients with Vitamin D deficiency, Administration of Cholecalciferol 2.5 mg (100 000 UI), once a month for 3 months

Primary Outcome Measures

Name	Time	Method
Change of the maximum walking distance on treadmill	baseline, 12 weeks and 24 weeks	the Walking distance will be assessed during a test on a treadmill according to a standardized procedure

Secondary Outcome Measures

Name	Time	Method
Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)	24 weeks	Prevalence and description of adverse events reported by the patient in a patient book and data collected at the end of treatment
Compliance with Vitamin D supplementation	24 weeks	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

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France