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

• ClinicalTrials.gov Identifier: NCT03615833
• Recruitment Status: Completed
• First Posted: August 6, 2018
• Last Update Posted: September 24, 2020
• Sponsor: University Hospital, Angers
• Information provided by (Responsible Party): University Hospital, Angers

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Drug: Cholecalciferol	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 27 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: March 11, 2019
• Actual Primary Completion Date: September 21, 2020
• Actual Study Completion Date: September 21, 2020

Arms and Interventions

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 Name: Vitamin D

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

CHU Angers

Angers, France, 49933

Sponsors and Collaborators

University Hospital, Angers

Investigators

• Principal Investigator: Samir Henni, MD, PhD; University Hospital, Angers

More Information

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT03615833
• Other Study ID Numbers: 2018-004146-41
• First Posted: August 6, 2018
• Last Update Posted: September 24, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Angers:

peripheral artery disease; Vitamin D

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents