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

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ClinicalTrials.gov Identifier: NCT03403933
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Tracking Information
First Submitted Date  ICMJE December 19, 2017
First Posted Date  ICMJE January 19, 2018
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE January 16, 2017
Actual Primary Completion Date September 23, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Effect of Calcifediol Supplementation on Cardiopathic Patients Undergoing Major Orthopedic Surgery (Vitamina D).
Official Title  ICMJE Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypovitaminosis D
  • Cardiovascular Diseases
Intervention  ICMJE 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.

Study Arms  ICMJE 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
Intervention: Drug: Didrogyl
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 11, 2018)
74
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 16, 2018
Actual Primary Completion Date September 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03403933
Other Study ID Numbers  ICMJE DYDRO-D
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Ortopedico Galeazzi
Study Sponsor  ICMJE Istituto Ortopedico Galeazzi
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Istituto Ortopedico Galeazzi
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP