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

Sponsor

Istituto Ortopedico Galeazzi (Other)

Overall Status

Completed

CT.gov ID

NCT03403933

Collaborator

(none)

Enrollment

Arm

17.9

Actual Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

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 :

Jan 16, 2017

Actual Primary Completion Date :

Sep 23, 2017

Actual Study Completion Date :

Jul 16, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Istituto Ortopedico Galeazzi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Ortopedico Galeazzi

ClinicalTrials.gov Identifier:

NCT03403933

Other Study ID Numbers:

DYDRO-D

First Posted:

Jan 19, 2018

Last Update Posted:

Dec 17, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rickets

Cardiovascular Diseases

Avitaminosis

Vitamin D Deficiency

Study Results

No Results Posted as of Dec 17, 2019