Pilot Study of Vitamin D Screening Use in Peripheral Arterial Disease Patient Over Maximum Distance Walking (First-BLINDOS)
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|ClinicalTrials.gov Identifier: NCT03615833|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 7, 2019
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|
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 (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months
- 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
- 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
- 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
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
|Contact: Samir Henni, MD, PhD||0(33)email@example.com|
|Contact: Pierre Abraham, MD, PhD||0(33)firstname.lastname@example.org|
|Angers, France, 49933|
|Contact: Samir HENNI, MD,PhD 33(0)241354617 email@example.com|
|Contact: Pierre ABRAHAM, MD, PhD 33(0)241354617 firstname.lastname@example.org|
|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|
|Principal Investigator:||Samir Henni, MD, PhD||University Hospital, Angers|