Vitamin D Supplementation on in Major Orthopedic Surgery

Phase 4

Completed

• Conditions: Hypovitaminosis D; Cardiovascular Diseases
• Interventions: Drug: Didrogyl

• Registration Number: NCT03403933
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

Study Timeline

• Study Start: 2017-01-16
• Primary Completion: 2017-09-23
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-19
• Study Completion: 2018-07-16
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cardiopathic patients in hypovitaminosis	Didrogyl	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

Primary Outcome Measures

Name	Time	Method
Evaluation of improvement of ejection fraction (FE)	6 months	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

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milan, Italy