Back to resultsVitamin D Supplementation on in Major Orthopedic Surgery
Primary Purpose
Hypovitaminosis D, Cardiovascular Diseases
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Didrogyl
Sponsored by
About this trial
This is an interventional treatment trial for Hypovitaminosis D
Eligibility Criteria
Inclusion Criteria:
- Age: > or equal to 55 years, < or equal to 85 years
- cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site
- patients with diagnosis: hypovitaminosis d
Exclusion Criteria:
- presence of neoplasm
- endocrinological pathologies excluding diabetes mellitus
- advanced chronic renal failure (GFR < 35 ml/min)
- pregnant women
- impossibility to participate to the rehabilitation protocol or to perform the established controls
Sites / Locations
- IRCCS Istituto Ortopedico Galeazzi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cardiopathic patients in hypovitaminosis
Arm Description
Didrogyl 10 ml: 10 drops a day to obtain levels of vitamin D > 30 ng /ml. Once these values are obtained lower the dose to 4-5 drops a day, with the aim, however, of keeping the plasma values between 30 and 60 ng/ml during 6 months of the study
Outcomes
Primary Outcome Measures
Evaluation of improvement of ejection fraction (FE)
Evaluation of improvement of ejection fraction (FE) or longitudinal strain calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency who underwent supplementation with calcifediol, during functional recovery after major orthopedic surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT03403933
First Posted
December 19, 2017
Last Updated
May 8, 2023
Sponsor
Istituto Ortopedico Galeazzi
1. Study Identification
Unique Protocol Identification Number
NCT03403933
Brief Title
Vitamin D Supplementation on in Major Orthopedic Surgery
Official Title
Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
September 23, 2017 (Actual)
Study Completion Date
July 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospective, monocentric study in open, aimed at evaluating the effects of supplementation with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing major orthopedic surgery.
Detailed Description
Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with calcifediol to reach vitamin D levels> 30 ng / ml within 6 months. The purpose of this study is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain) calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency during functional recovery after major orthopedic surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D, Cardiovascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cardiopathic patients in hypovitaminosis
Arm Type
Experimental
Arm Description
Didrogyl 10 ml: 10 drops a day to obtain levels of vitamin D > 30 ng /ml. Once these values are obtained lower the dose to 4-5 drops a day, with the aim, however, of keeping the plasma values between 30 and 60 ng/ml during 6 months of the study
Intervention Type
Drug
Intervention Name(s)
Didrogyl
Intervention Description
Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels> 30 ng / ml are obtained.
Once these values have been obtained, the dosage can be reduced to a dosage of 4/5 drops of calcifediol (1 drop contains 5mcg of calcifediol) with the aim to maintain the plasma values of 25 (OH) D in a optimal range between 30-60 ng / ml during the 6 month of the duration of the study.
Primary Outcome Measure Information:
Title
Evaluation of improvement of ejection fraction (FE)
Description
Evaluation of improvement of ejection fraction (FE) or longitudinal strain calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency who underwent supplementation with calcifediol, during functional recovery after major orthopedic surgery
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: > or equal to 55 years, < or equal to 85 years
cardiopathic patients (including hypertension) who must undergo major orthopedic surgery at our site
patients with diagnosis: hypovitaminosis d
Exclusion Criteria:
presence of neoplasm
endocrinological pathologies excluding diabetes mellitus
advanced chronic renal failure (GFR < 35 ml/min)
pregnant women
impossibility to participate to the rehabilitation protocol or to perform the established controls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Turiel
Organizational Affiliation
IRCCS Istituto Ortopedico Galeazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milan
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Supplementation on in Major Orthopedic Surgery
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