Nutritional Support in Femur Fracture Rehabilitation
Launched by BARICHELLA MICHELA · Mar 10, 2020
Trial Information
Current as of June 10, 2025
Unknown status
Keywords
ClinConnect Summary
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. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with su...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • age 60 years or older
- • admission for physical rehabilitation after surgery for femur fracture
- • informed consent
- Exclusion Criteria:
- • 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:
- • 1. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
- • 2. More than 500 mg of daily calcium intake from medical sources.
- • 3. Adherence to a high-energy or high-protein diet (up to three months before starting the study)
- • 4. 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
About Barichella Michela
Barichella Michela is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative therapeutic solutions. With a focus on rigorous scientific methodology and ethical standards, the organization collaborates with a diverse range of healthcare professionals and institutions to design and implement clinical trials that address unmet medical needs. Barichella Michela prioritizes transparency, safety, and integrity in all its research endeavors, aiming to contribute valuable insights to the medical community and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Patients applied
Trial Officials
Lorenzo Panella, MD
Principal Investigator
ASST Gaetano Pini-CTO
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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