Vitamin D Supplementation on in Major Orthopedic Surgery

NCT ID: NCT03403933

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-16
• Study Completion Date: 2018-07-16

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.

Conditions

Hypovitaminosis D; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Didrogyl

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Turiel

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituto Ortopedico Galeazzi

Locations

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Countries

Italy

Other Identifiers

L4073

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Vitamina D (PI: M Turiel)

Identifier Type: -

Identifier Source: org_study_id