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
|Condition or disease||Intervention/treatment||Phase|
|Hypovitaminosis D Cardiovascular Diseases||Drug: Didrogyl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of the Effect of Calcifediol Supplementation on Left Ventricular Function in Cardiopathic Patients Undergoing Major Orthopedic Surgery.|
|Actual Study Start Date :||January 16, 2017|
|Actual Primary Completion Date :||September 23, 2017|
|Actual Study Completion Date :||July 16, 2018|
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
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) [ 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