A Phase 4 interventional study of Didrogyl in Hypovitaminosis D and Cardiovascular Diseases, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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
Time frame: 6 months
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio