Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking (First-BLINDOS)

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.

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 .

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Drug: Cholecalciferol

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • CHU Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Cholecalciferol; Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months; Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Samir HENNI, MD, PhD, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Vitamin D; peripheral artery disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2018-004146-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No