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Protein powder fails to prove recovery boost in tiny hip fracture trial

NCT ID NCT04306536

Symptom relief Sponsor: Barichella Michela Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This small trial tested whether adding a special protein-and-vitamin powder to the diet could help older adults walk better after surgery for a broken femur. Only 20 people took part, and the study was stopped early. The main goal was to see if the supplement improved walking speed, but the early termination means we cannot draw firm conclusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fortifit (a protein, vitamin, and mineral powder supplement)
What this could lead to
If it worked, this could point toward a simple nutritional strategy to improve physical recovery after hip fracture surgery in older adults.
What could go wrong
The trial was terminated early and enrolled only 20 people, so results are very limited. It is unclear if the supplement provides any real benefit over standard diet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Jun 2020

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age 60 years or older * admission for physical rehabilitation after surgery for femur fracture * informed consent Exclusion Criteria: * 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) * Indications related to the study product: 1. More than 10 µg (400 IU) of daily Vitamin D intake from medical sources 2. More than 500 mg of daily calcium intake from medical sources. 3. Adherence to a high-energy or high-protein diet (up to three months before starting the study) 4. 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 * Inclusion in other nutrition intervention trials * Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements * Refusal

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Conditions

The condition(s) this trial relates to.

Femoral Fractures femoral neck fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Femur fracture

Contacts and locations

Locations

  • Asst Gaetano Pini

    Milan, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.