A Prospective Randomized Trial Comparing the Effect of 2 vitamin D supplementation regimens in elderly people after hip fracture surgery

eonor Cuadra Llopart0 个研究点开始时间: 2017年10月2日最近更新: 2017年10月23日

适应症

试验速览

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•Patients aged > or =75 years with hip fracture by fragility and vitamin D deficiency.
•Definitions:
•* Fracture by fragility: understood as such those that are produced by trauma of low intensity (for example, falls from the own height in standing or smaller)
•* Vitamin D deficiency: 25-OH-D3 serum levels <30 ng / mL
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•* Presence of severe functional dependence prior to fracture of the femur (I. Barthel <35 points)
•* Diagnosis of dementia to a moderate degree (defined on the Reisberg scale as GDS-FAST> 5).
•* Medical conditions that contraindicate receiving vitamin D supplementation
•- hypercalcemia (calcemia> 10.5 mg / dL),
•- hyperparathyroidism
•- chronic renal failure with GFR <30 mL / min,
•- calcium lithiasis
•- pathologies with risk of hypercalcemia (tuberculosis, sarcoidosis ...), as well as pathologies involving intestinal malabsorption.
•- Hypersensitivity to the active substance or to any of the excipients.
•* Use of drugs that interact with the use of vitamin D and with the risk of causing hypercalcemia (phenytoin, phenobarbital, primidone, digoxin).
•* Reduced life expectancy (<12 months) due to the presence of advanced concomitant or end-of-life conditions.

发起方

eonor Cuadra Llopart