The effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on muscle strength in a frail elderly population: A randomized, double-blind, placebo-controlled trial. - D-Fit

Wageningen Universiteit0 个研究点目标入组 78 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- 25(OH)D levels 20-50 nmol/L.
•- age 65 or older.
•- male or female gender.
•- physically pre-frail or frail
•- body mass index between 18.5 and 35 kg/m2.
•- willingness and ability to comply with the protocol, including performance of the knee extension strenght test.

•- Medical illness: malabsorption syndrome (known intestinal malabsorption, celiac diseases, inflammatory bowel disease), diseases that may enhance serum calcium concentration (sarcoidosis, lymphoma, kidney stone in last 10 years, primary hyperparathyroidism), abnormal indices of calcium metabolism, uncontrolled hypocalcaemia, diagnosed renal insufficiency, diagnosed cancer (currently diagnosed or undergoing treatment)
•- Hypercalcemia: serum calcium adjusted for albumin of > 2.6 nmol/L.
•- Medication: interfering with vitamin D metabolism and vitamin D supplementation; bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica, bile acid sequestrate (Colestyramine, Colestipol) and lipase inhibitors (Orlistat).
•- Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study.
•- (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period.
•- Patient heavily consumes alcohol containing products defined as greater than > 21 drinks of alcoholic beverages per week.
•- Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery).
•- Participation in another clinical trial.
•- Subjects taking anticoagulation medication (with an exception of platelet inhibitors like aspirin) will be included in the study, but excluded from the muscle biopsy procedure.

发起方