Hip FracturePhase 3NCT01011608
Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Surgery
A Phase 3 study testing Medical Food Supplement and standard hospital food in people with Hip Fracture, run by Abbott Nutrition at 11 sites in Russia.
Trial summary
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Medical Food Supplement and standard hospital food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 11 sitesRussia
- Study dates
- Nov 2009to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 45 years of age.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- Subject plans to undergo hip fracture surgery.
- Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
- Subject has admission total protein ≤ 70 g/L.
- Subject has screening serum albumin ≤ 38 g/L.
Who cannot join
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
- Subject has pre-planned surgery other than hip fracture surgery during the study period.
- Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- Subject has active malignancy
- Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has diagnosis of IDDM.
- Subject has uncontrolled NIDDM determined by HbA1c > 8%.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Russia11 sites
Regional Clinical Hospital #1
Krasnodar, 350086
City Clinical Hospital #15
Moscow, 111539
City Clinical Hospital #12
Moscow, 115516
City Clinical Hospital #31
Moscow, 119415
City Clinical Hospital n.a. Botkina
Moscow, 125284
State Novosibirsk Regional Hospital
Novosibirsk, 630087
Alexandrovskaya City Hospital
Saint Petersburg, 193312
Saint Petersburg State Medical Academy Mechnikova
Saint Petersburg
Samara Regional Clinical Hospital
Samara, 443095
Ufa Medical University, Hospital of Emergency Care
Ufa, 450092
Ural State Medical Academy
Yekaterinburg, 620007
About this study
Official title: Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.
- Conditions
- Hip Fracture
- Being tested
- Medical Food Supplement, standard hospital food
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food SupplementOther
Medical Food Supplement to be given in divided portions in morning, afternoon and evening
standard hospital foodOther
standard hospital diet ad. lib.
| Study group | Role | What they receive |
|---|---|---|
| Medical Food Supplement | Experimental | Medical food supplement to be given in divided portions in morning, afternoon and evening Receives: Other: Medical Food Supplement |
| standard hospital food | Active comparator | standard hospital diet Receives: Other: standard hospital food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood chemistry
Measured: 28 days
Secondary outcomes (3)
Product intake
Measured: 28 days
Functionality (pain, mobility, strength)
Measured: 28 days
Surgical site status
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Anne C Voss, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011608
- Sponsor's protocol ID
- BK52
- Status last verified
- Nov 2010
- First submitted
- 10 Nov 2009
- Last updated
- 4 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Medical Food Supplement in Hospitalized Patients Recovering From Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT01011608
- Acronym / sponsor ID
- BK52
- Conditions
- Hip Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the effect of nutritional supplementation on the nutritional and clinical course of patients admitted to the hospital for hip fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Food Supplement | Experimental | Other: Medical Food SupplementMedical food supplement to be given in divided portions in morning, afternoon and evening |
| standard hospital food | Active comparator | Other: standard hospital foodstandard hospital diet |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is > 45 years of age.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- Subject plans to undergo hip fracture surgery.
- Subject has anticipated length of hospital stay of at least 4 weeks. Subject is able to consume foods and beverages orally.
- Subject has admission total protein ≤ 70 g/L.
Key exclusion criteria (7 listed)
- Subject is known to be allergic or intolerant to any ingredient found in the study product.
- Subject has pre-planned surgery other than hip fracture surgery during the study period.
- Subject has alcohol or substance abuse, severe dementia, brain metastases, eating disorders or any psychological condition that may interfere with dietary intake, severe nausea, vomiting, diarrhea, active gastritis, gastrointestinal bleeding or other gastrointestinal disturbances.
- Subject has active malignancy
- Subject has chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Food SupplementMedical Food Supplement to be given in divided portions in morning, afternoon and evening | Other | Medical Food Supplement |
| standard hospital foodstandard hospital diet ad. lib. | Other | standard hospital food |
Primary outcome
Blood chemistry
Time frame: 28 days
3 secondary outcomes
Product intake
Time frame: 28 days
Functionality (pain, mobility, strength)
Time frame: 28 days
Surgical site status
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne C Voss, PhD study chair
Abbott Nutrition
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medical Food Supplement and standard hospital food in people with Hip Fracture, run by Abbott Nutrition at 11 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood chemistry (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2011.