Vitamin D Supplementation on in Major Orthopedic Surgery

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status and phase: Completed; Phase 4

Conditions: Cardiovascular Diseases; Hypovitaminosis D

Treatments: Drug: Didrogyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03403933

Vitamina D (PI: M Turiel)

L4073 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

cardiopathic patients in hypovitaminosis

Experimental group

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

Treatment:

Drug: Didrogyl