NCT01850251

Brief Summary

The purpose of this study is to determine whether a nutritional supplement high in protein and energy, and enriched with hydroxymethylbutyrate (HMB) and vitamin D is more effective than a standard nutritional supplement high in protein and energy in improving muscle strength in elderly patients with hip fracture.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.7 years

First QC Date

May 3, 2013

Last Update Submit

August 18, 2015

Conditions

Hip Fractures

Keywords

Hip fracturesAgeingSarcopeniaFunction

Outcome Measures

Primary Outcomes (1)

  • Change in bilateral knee extension test as a measure of isometric muscle strength.

    Changes from baseline in the knee extension test at 8 weeks will be conducted using a dynamometer.

    Baseline and 8 weeks

Secondary Outcomes (1)

  • Change in the Timed Up & Go test as a measure of function.

    Baseline and 8 weeks

Other Outcomes (1)

  • Quality of life

    Baseline and 8 weeks

Study Arms (2)

Supplement with HMB and vitamin D

EXPERIMENTAL

Oral administration of 440 mL (2 bottles) of nutritional supplement with HMB and vitamin D each day during 8 weeks.

Dietary Supplement: Supplement with HMB and vitamin D

Standard nutritional supplement

ACTIVE COMPARATOR

Oral administration of 440 mL (2 bottles) of standard nutritional supplement each day during 8 weeks.

Dietary Supplement: Standard nutritional supplement

Interventions

Supplement with HMB and vitamin DDIETARY_SUPPLEMENT

High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.

Also known as: Ensure Plus Advance
Supplement with HMB and vitamin D
Standard nutritional supplementDIETARY_SUPPLEMENT

High protein, high calorie nutritional supplement.

Also known as: Ensure Plus High Protein
Standard nutritional supplement

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients over 65 years of age after hip fracture surgery.
  • Ability to walk before fracture.

You may not qualify if:

  • Chronic renal failure, defined as a glomerular filtration rate less than 60 mL/min/1.73 m2, or serum creatinine of 0.9 mg/dL in women or 1.2 mg/dL in men.
  • Following a diet with protein restriction.
  • Need for enteral or parenteral nutrition.
  • Need for medication with orexigenic or anabolic effect, or long-term corticosteroids.
  • Active neoplastic disease.
  • Cognitive impairment or major psychiatric disorder.
  • Lack of signed informed consent.
  • Any patient with inability to comply with treatment or not appropriate according to the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Related Publications (1)

  • Fuller JC Jr, Baier S, Flakoll P, Nissen SL, Abumrad NN, Rathmacher JA. Vitamin D status affects strength gains in older adults supplemented with a combination of beta-hydroxy-beta-methylbutyrate, arginine, and lysine: a cohort study. JPEN J Parenter Enteral Nutr. 2011 Nov;35(6):757-62. doi: 10.1177/0148607111413903. Epub 2011 Aug 1.

    PMID: 21807930BACKGROUND

MeSH Terms

Conditions

Hip FracturesSarcopenia

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Maria T Forga, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Joan Trabal, RD, MS

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Pere Leyes, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Salvi Prat, MD, PhD

    Hospital Clinic of Barcelona

    STUDY CHAIR

  • Margarita Navarro, MD

    Hospital Clinic of Barcelona

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 9, 2013

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

ES(1)