Vitamin D Supplementation on in Major Orthopedic Surgery

NCT03403933 | Completed Phase 4

• 2 other identifiers: Vitamina D (PI: M Turiel)L4073
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Evaluation of improvement of ejection fraction (FE)

  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

  6 months

Study Arms (1)

cardiopathic patients in hypovitaminosis

EXPERIMENTAL

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

Interventions

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.

cardiopathic patients in hypovitaminosis

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, Italy

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Maurizio Turiel

  IRCCS Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 19, 2018
• Study Start: January 16, 2017
• Primary Completion: September 23, 2017
• Study Completion: July 16, 2018
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

IT (1)