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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 February 2016 |
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Main ID: |
NCT01404195 |
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Date of registration:
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22/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Hyperprotein Nutritional Intervention in Elderly Patients With Hip Fracture and Sarcopenia
HIPERPROT |
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Scientific title:
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High-protein Nutritional Intervention Based on ß-hydroxy-ß-methylbutirate, Vitamin D3 and Calcium on Obese and Lean Aged Patients With Hip Fractures and Sarcopenia. The HIPERPROT-GER Study. |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01404195 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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M Angeles Zulet, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Navarra |
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Name:
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Vincenzo Malafarina, MD Msc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Clinica Los Manzanos, Lardero, Spain |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients aged 65 years or older
- Diagnosis of traumatic hip fracture
- Patients admitted for rehabilitation
- Patients signing informed consent.
Exclusion Criteria:
- Stage 4 renal failure
- Child C stage hepatic insufficiency
- Barthel index < 20 in the six months prior to admission
- Dysphagia for liquids
- Active oncological disease who are receiving treatment
- Severe clinical conditions compromising and threatening their lives
- Morbid obesity (BMI > 40)
- BMI < 21 kg/m2
- Albumin levels < 2.1 g/dL
- MNA < 11
- Charlson index = 6
- diabetes mellitus
- Patients not doing rehabilitation.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hip Fracture
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Sarcopenia
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Intervention(s)
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Dietary Supplement: Ensure Plus Advance
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Primary Outcome(s)
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Change from baseline in Barthel index
[Time Frame: On admission to hospital and at discharge.]
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Secondary Outcome(s)
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Death for any cause
[Time Frame: During admission]
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Univariate analysis of the relationship between levels of IL-1, IL-6 and TNF-alpha and values of bioelectrical impedance
[Time Frame: On admission to hospital and at discharge]
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Change from baseline in strength will be measured in the dominant hand using a portable JAMAR dynamometer
[Time Frame: On admission to hospital and at discharge.]
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Change from baseline in bioelectrical impedance analysis
[Time Frame: On admission to hospital and at discharge.]
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Prevalence of sarcopenia
[Time Frame: hospital admission]
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Secondary ID(s)
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ViamedValvaSarcoHF
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HSJDPAM01SARCOP2011
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HVVV-Log-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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