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Simple supplement may cut infection risk after leg fracture surgery

NCT ID NCT07155447

Disease control Sponsor: University of Minnesota Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 3 times

Summary

This study tests whether a daily drink containing specific amino acids can reduce infections, improve bone healing, and prevent muscle loss after surgery for severe leg fractures. About 1,000 adults aged 18–55 with lower leg fractures will receive either the supplement or a placebo for 28 days starting within 72 hours of injury. Researchers will track complications for a year to see if this low-cost, low-risk approach makes a real difference.

What this could mean

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

Active substance
Conditionally essential amino acid (CEAA) supplement (calcium beta-hydroxy-beta-methylbutyrate monohydrate, L-Arginine, L-Glutamine, and Citrulline)
What this could lead to
If it works, this could offer a simple, low-cost way to reduce serious complications like infections and poor bone healing after leg fracture surgery.
What could go wrong
This is a large phase 3 trial, but supplements often show less benefit in real-world settings than in early studies. The results may not apply to all fracture types or ages.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 to 55 years

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: 1. Adults age 18-55 years 2. Open or closed fracture of the lower extremity including femur, tibia and/or fibula, calcaneus, talus, Lisfranc joint (OTA/AO 31, 32, 33, 41, 42, 43, 44, 4F, 81, 82, 83, 85) 3. Ability to begin supplementation within 72 hours of injury Exclusion Criteria: 1. BMI \<18.5 kg/m 2 (underweight) or BMI \> 45 kg/m 2 (severe obesity) to exclude patients with severely increased baseline risk of adverse outcome due to preoperative poor nutrition 2. Non-ambulatory prior to injury 3. Currently pregnant 4. Medical contraindication to CEAA supplementation (e.g., phenylketonuria) 5. Inability to provide informed consent due to intellectual disability 6. Protected populations (e.g., prisoners) 7. Inability to follow up (e.g., homeless at time of surgery, home address out of state of treating facility) 8. Documented dementia, mild or moderate traumatic brain injury 9. Inability to consume supplement or placebo due to head or neck trauma 10. Low-energy fragility fracture (i.e. ground level falls) 11. Pathologic fracture (i.e. fracture through site of compromised bone due to infection, neoplasm, documented osteoporosis, metabolic bone disease from conditions such as end stage renal disease, osteomalacia, hypophosphatemic rickets, renal osteodystrophy, osteofibrous dysplasia)

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As listed by the trial registrant

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

Lower extremity fracture

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