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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615833
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: Cholecalciferol Not Applicable

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 )

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615833


Contacts
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Contact: Samir Henni, MD, PhD 0(33)241354617 samir.henni@chu-angers.fr
Contact: Pierre Abraham, MD, PhD 0(33)241354617 piabraham@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Samir HENNI, MD,PhD    33(0)241354617    samir.henni@chu-angers.fr   
Contact: Pierre ABRAHAM, MD, PhD    33(0)241354617    piabraham@chu-angers.fr   
Principal Investigator: Samir Henni, MD, PhD         
Sub-Investigator: Pierre Abraham, MD, PhD         
Sub-Investigator: Jean Piquet, MD, PhD         
Sub-Investigator: Phillipe Bouyé, MD         
Sub-Investigator: Marie-Sophie Fernandez-Legrand, MD         
Sub-Investigator: Anne-Sophie Gourdier, MD         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Samir Henni, MD, PhD University Hospital, Angers
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03615833    
Other Study ID Numbers: 2018-004146-41
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: March 2019

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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:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cholecalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents