Vitamin D Supplementation on in Major Orthopedic Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03403933

Enrollment

Registered

2018-01-19

Start date

2017-01-16

Completion date

2018-07-16

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Hypovitaminosis D

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.

Interventions

DRUGDidrogyl

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026