Pilot Study of Vitamin D Screening Use in Peripheral Arte... | NCT03615833

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

NCT03615833

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Sep 24, 2020Actual

Enrollment

27Actual

Phase

Phase 4

Conditions

Peripheral Arterial Disease

Interventions

Cholecalciferol

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Actual

Primary Completion Date

Sep 21, 2020Actual

Completion Date

Sep 21, 2020Actual

First Submitted Date

Jul 30, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Aug 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2020

Last Update Posted Date

Sep 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

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 )

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months	Patients with Vitamin D deficiency

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samir Henni, MD, PhD	University Hospital, Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Angers		Angers		49933	France

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol
D014807	Vitamin D

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided