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Study of the Effect of Calcifediol Supplementation on Cardiopathic Patients Undergoing Major Orthopedic Surgery (Vitamina D).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03403933
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : December 17, 2019
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Cardiovascular Diseases Drug: Didrogyl Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery.
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : September 23, 2017
Actual Study Completion Date : July 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol

Arm Intervention/treatment
Experimental: cardiopathic patients in hypovitaminosis
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
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.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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
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Responsible Party: Istituto Ortopedico Galeazzi Identifier: NCT03403933    
Other Study ID Numbers: DYDRO-D
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Vitamin D Deficiency
Deficiency Diseases
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders