Vitamin D Supplementation on in Major Orthopedic Surgery

NCT03403933 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2023-05-09

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Maurizio Turiel · IRCCS Istituto Ortopedico Galeazzi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2017-09-23
Completion
2018-07-16

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403933 on ClinicalTrials.gov