Hip Fracture Surgery and Oral Nutritional Supplements (HIATUS)
Effect of a Nutritional Intervention on Hip Fracture Surgery Recovery
Studienübersicht
Status
Status
Bedingungen
Bedingungen
Intervention / Behandlung
Intervention / Behandlung
Studientyp
Studientyp
Einschreibung (Tatsächlich)
Einschreibung
Phase
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Zurich, Schweiz, 8091
- University of Zurich,Dept. of Rheumatology and Institute of Physical Medicine,
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Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age (70+);
- Had an acute hip fracture and surgical treatment
- Able to walk at least 3 meters without assistance of another person, with or without a walking aid other than a wheeled walker prior to hip fracture MMSE >=18 (proxy will be informed in addition if MMS-score ≤ 24)
- Able to perform the SPPB at baseline
- No prior hip fracture
- Patient (and/or his/her legal representatives/relatives) understands the study procedure, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving his/her (or his/her legal representative's/relatives) written informed consent.
Exclusion Criteria:
- Baseline visit can not be performed between the second and tenth postoperative day.
- Milk protein allergy
- Patients with conservative treatment for hip fracture
- Serum calcium adjusted for albumin of > 2.6 mmol/L
- Pathologic fracture in the last year (except for fractures due to osteoporosis)
- Chemo therapy / Radiation /antihormonal therapy due to cancer in the last year
- Treatment which has an effect on calcium metabolism (e.g. PTH, calcitonin, chronic cortisone intake > 5mg/day in the last 12 months (except for inhalation and sporadic infiltration))
- Oral vitamin D intake of more than 1000 IU per day during the last 3 months before the study
- Unwilling to stop multi-vitamin, calcium supplementation, and vitamin D supplementation during the trial (maximal calcium supplement intake 250mg/d; no additional vitamin D supplementation). We will inform the treating physician that we initiated vitamin D supplementation as standard of care.
- Severe visual or hearing impairment
- Unwilling or unable to take study medication
- Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope) BMI ≥ 40
- Estimated creatinine clearance < 15 ml/min (estimated Creatinine Clearance cockcroft and Gault)
- Malabsorption syndrome (celiac diseases, inflammatory bowel disease, hepatic and/or pancreas dysfunction)
- Diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
- Kidney stone in the last 10 years
- Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
- Patients who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than one month during the trial
- Medication which has an effect on serum 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin) M. Paget (Ostitis deformans)
- Inflammatory arthritis (e.g. rheumatoid arthritis, reiter syndrome, psoriasis arthritis)
- Uncontrolled metabolic conditions, or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult
- Severe acute and/or chronic disease that makes the performance of the study assessments impossible (e.g. severe infection/sepsis, myocardial infarction, heart failure, respiratory failure or renal failure);
- Patient is taking peripherally acting anti-adiposity drugs (e.g. Xenical®, formoline L112®, (Acomplia®))
- Patients taking protein supplements (>15g per serving more than once a week) or are unwilling to stop any protein supplements during the trial Participation in a study in the last 6 month, except for studies without drug-application, or any influence of the study-medication can be excluded
- Patient is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
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Placebo-Komparator: Placebo
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placebo product with no specific nutrients
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Experimental: Specialized Oral Nutritional Supplement
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Specialized nutritional supplement for seniors
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Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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The Short Physical Performance Battery (SPPB)
Zeitfenster: 6 months
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6 months
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Sekundäre Ergebnismessungen
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Lebensqualität
Zeitfenster: 6 Monate
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6 Monate
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Nutritional status
Zeitfenster: 6 months
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6 months
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Muscle strength
Zeitfenster: 6 months
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6 months
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Mitarbeiter und Ermittler
Sponsor
Sponsor
Ermittler
Ermittler
- Hauptermittler: Heike Bischoff-Ferrari,, MD, DrPH, University of Zurich
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienbeginn
Primärer Abschluss (Tatsächlich)
Primärer Abschluss
Studienabschluss (Tatsächlich)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- NES1026CLI
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