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

NCT03615833 | Completed Phase 4

• 1 other identifier: 2018-004146-41
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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 .

Conditions

Peripheral Arterial Disease

Keywords

peripheral artery disease; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance of vitamin D supplementation during 12 weeks of treatment (period 2)

  24 weeks

• Compliance with Vitamin D supplementation

  24 weeks

Study Arms (1)

Patients with Vitamin D deficiency

EXPERIMENTAL

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

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D

Patients with Vitamin D deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting a Peripheral Arterial Disease (Stage 2)
• Affiliation to the French National healthcare system
• French speaking patients

You may not qualify if:

• Pregnancy
• Inability to understand the study goal
• Patients protected by decision of law

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Cholecalciferol; Vitamin D

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Samir Henni, MD, PhD

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 6, 2018
• Study Start: March 11, 2019
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

FR (1)