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Hohenheim Malnutrition Study in Geriatric Fracture Patients (HohMal2)

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ClinicalTrials.gov Identifier: NCT03493100
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
University of Hohenheim

Brief Summary:
The aim of this study is to evaluate long-term effects of early and prolonged individualized and optimized nutritional support using ONS for four weeks, in combination with a defined physiotherapy regimen, on sarcopenia and other outcome parameters in elderly fracture patients.

Condition or disease Intervention/treatment Phase
Geriatric Patients Dietary Supplement: oral nutritional supplementation Other: Usual care Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Oral Nutritional Supplementation in Geriatric Fracture Patients on Muscle Functionality, Quality of Life and Nutritional Status
Actual Study Start Date : September 15, 2016
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: oral nutritional supplementation
This group receives optimized nutritional support, by ONS for a period of four weeks.
Dietary Supplement: oral nutritional supplementation
The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.

Control
The control group will receive treatment according to usual care.
Other: Usual care
The control group will receive treatment according to usual care.




Primary Outcome Measures :
  1. hand grip strength [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    The primary endpoint is the change in muscle functionality of the study groups after 4 weeks by the measurement of hand grip strength using Jamar®-Dynamometer.


Secondary Outcome Measures :
  1. Nutritional status [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Mini Nutritional Assessment (MNA).

  2. Mobility [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Elderly Mobility Scale (EMS).

  3. Arm/leg circumference [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  4. Extracellular to body cell mass ratio (ECM/BCM - Ratio) [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  5. Skinfold thickness [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  6. Quality of life [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up. Measured using Activity of daily living (ADL) questionnaire and EQ-5-DL questionnaire.

  7. Comorbidity rate [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  8. Medical condition [ Time Frame: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks.

  9. Sarcopenia prevalence [ Time Frame: Participants will be followed from day 1 to day 180.Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks.

  10. Phase angle [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place at discharge, after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  11. Routine laboratory tests (serum plasma) [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  12. Vitamin D in serum [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  13. Vitamin B12 in serum [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  14. Folic acid in serum [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  15. CRP (C-reactive protein) in serum [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference in blood serum between intervention and control group at discharge and after 4 weeks follow-up.

  16. BCM (body cell mass) [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  17. Body weight [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.

  18. BMI (body mass index) [ Time Frame: Participants will be followed from day 1 to day 180. Examinations take place after 4 weeks, after 3 months and after 6 months. ]
    Difference between intervention and control group at discharge and after 4 weeks follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 75 years, or
  • age ≥ 65 years and Carlson-Comorbidity-Index of ≥ 5 and
  • written informed consent

Exclusion Criteria:

  • progressive cancer disease
  • relevant pre-existing chronic conditions (in order to avoid disease related impact on outcome parameters)
  • insufficient German speech intelligibility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493100


Contacts
Contact: Maryam Basrai m.basrai@uni-hohenheim.de

Locations
Germany
University of Hohenheim Recruiting
Stuttgart, Germany, 70599
Contact: Maryam Basrai       m.basrai@uni-hohenheim.de   
Principal Investigator: Stephan C. Bischoff         
Sponsors and Collaborators
University of Hohenheim
Investigators
Principal Investigator: Stephan C. Bischoff University of Hohenheim

Responsible Party: University of Hohenheim
ClinicalTrials.gov Identifier: NCT03493100     History of Changes
Other Study ID Numbers: HohMal2
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Hohenheim:
oral nutritional supplementation
geriatrics
bone fracture