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Completed

NCT Number: NCT03403933

Vitamin D Supplementation on in Major Orthopedic Surgery

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.

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Key information

Conditions

Hypovitaminosis D Avitaminosis Cardiovascular Diseases Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Didrogyl

Drug

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 outcomes

  1. Evaluation of improvement of ejection fraction (FE)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jan 19, 2018
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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