Status:
TERMINATED
Nutritional Support in Femur Fracture Rehabilitation
Lead Sponsor:
Barichella Michela
Conditions:
Femur Fracture
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation p...
Detailed Description
Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femu...
Eligibility Criteria
Inclusion
- age 60 years or older
- admission for physical rehabilitation after surgery for femur fracture
- informed consent
Exclusion
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate \<30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Severe cognitive impairment (Mini Mental State Examination \<18)
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- Indications related to the study product:
- More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
- More than 500 mg of daily calcium intake from medical sources.
- Adherence to a high-energy or high-protein diet (up to three months before starting the study)
- Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)
- Indication to or ongoing artificial nutrition support
- Inclusion in other nutrition intervention trials
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04306536
Start Date
June 19 2020
End Date
December 20 2020
Last Update
September 4 2025
Active Locations (1)
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1
Asst Gaetano Pini
Milan, Italy