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NCT03403933 Clinical Trial

Vitamin D Supplementation on in Major Orthopedic Surgery

Cardiovascular Diseases Clinical Trial

Official title:
Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03403933
Other study ID # Vitamina D (PI: M Turiel)
Secondary ID L4073
Status Completed
Phase Phase 4
First received
Last updated
Start date January 16, 2017
Est. completion date July 16, 2018

Study information
Verified date May 2023
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date July 16, 2018
Est. primary completion date September 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Didrogyl
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.

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 months
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