Femur FractureNCT04306536
Nutritional Support in Femur Fracture Rehabilitation
A study testing Fortifit® in people with Femur Fracture, run by Barichella Michela at 1 site in Italy.
Trial summary
This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Fortifit®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jun 2020to 20 Dec 2020
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60 years or older
- admission for physical rehabilitation after surgery for femur fracture
- informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Who cannot join
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Severe cognitive impairment (Mini Mental State Examination <18)
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
Show all 12Show fewer
- Indications related to the study product:
- More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
- More than 500 mg of daily calcium intake from medical sources.
- Adherence to a high-energy or high-protein diet (up to three months before starting the study)
- Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)
- Indication to or ongoing artificial nutrition support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
Read the detailed description
Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
- Conditions
- Femur Fracture
- Being tested
- Fortifit®
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortifit®Dietary supplement
Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
| Study group | Role | What they receive |
|---|---|---|
| Fortifit® | Experimental | Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. Receives: Dietary Supplement: Fortifit® |
| Control group | No intervention | Best local diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical performance - gait speed
Gait speed at the 10-meter walking test
Measured: 4 weeks
Secondary outcomes (10)
Physical performance - Timed Up and Go test
Change in timed up and go test
Measured: 4 weeks
Functional status - Barthel
Change in Barthel index score
Measured: 4 weeks
Functional status - handgrip strength
Change in handgrip strength
Measured: 4 weeks
Body composition - phase angle
Change in phase angle
Measured: 4 weeks
Body composition - muscle mass
Change in muscle mass
Measured: 4 weeks
Body composition - fat-free mass
Change in fat-free mass
Measured: 4 weeks
Body composition - fat-free mass index
Change in fat-free mass index
Measured: 4 weeks
Body weight
Change in body weight
Measured: 4 weeks
Calf circumference
Change in calf circumference
Measured: 4 weeks
Modality of discharge
Difference in the proportion of patients discharged at home
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start19 Jun 2020
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Why it stopped: COVID Pandemic and change in surgical activities in the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barichella Michela
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Barichella Michela, ASST Gaetano Pini-CTO
- Investigators
- Lorenzo Panella, MD, Principal investigator, ASST Gaetano Pini-CTO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306536
- Sponsor's protocol ID
- parere 72_2020bis
- Status last verified
- Aug 2025
- First submitted
- 10 Mar 2020
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle-targeted Nutritional Support in Post-surgical Rehabilitation for Femur Fracture
- ClinicalTrials.gov ID
- NCT04306536
- Acronym / sponsor ID
- parere 72_2020bis
- Conditions
- Femur Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID Pandemic and change in surgical activities in the institution
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barichella MichelaUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 13 Mar 2020 (actual)
- 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.
This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
Detailed description
Muscle-target nutritional supplementation has been domonstrated to enhance the recovery of muscle mass and increase the efficacy of a rehabilitation program in patients suffering from sarcopenia. Femure fracture is responsible for increased immobilization resulting in loss of muscle mass which may be further emphasized by surgical stress. This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortifit® | Experimental | Dietary Supplement: Fortifit®Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
| Control group | No intervention | –Best local diet |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 60 years or older
- admission for physical rehabilitation after surgery for femur fracture
- informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Key exclusion criteria (12 listed)
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Severe cognitive impairment (Mini Mental State Examination <18)
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 |
|---|---|---|
| Fortifit®Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. | Dietary supplement | Fortifit® |
Primary outcome
Physical performance - gait speed
Time frame: 4 weeks
Gait speed at the 10-meter walking test
10 secondary outcomes
Physical performance - Timed Up and Go test
Time frame: 4 weeks
Functional status - Barthel
Time frame: 4 weeks
Functional status - handgrip strength
Time frame: 4 weeks
Body composition - phase angle
Time frame: 4 weeks
Body composition - muscle mass
Time frame: 4 weeks
Body composition - fat-free mass
Time frame: 4 weeks
Body composition - fat-free mass index
Time frame: 4 weeks
Body weight
Time frame: 4 weeks
Calf circumference
Time frame: 4 weeks
Modality of discharge
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: COVID Pandemic and change in surgical activities in the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
Lorenzo Panella, MD principal investigator
ASST Gaetano Pini-CTO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortifit® in people with Femur Fracture, run by Barichella Michela at 1 site in Italy.
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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
Are results available for this study?
The study was stopped early (reason given: COVID Pandemic and change in surgical activities in the institution). Results are not available in the source record.
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?
Physical performance - gait speed (time frame: 4 weeks). 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 Sep 2025.