Naringenin Supplementation in Bone Fracture Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShahid Beheshti University of Medical Sciences

About this trial

Fractures of the lower extremities represent a significant proportion of injuries sustained by polytrauma patients, with a notable association with prolonged hospitalization, chronic disability, and impaired physical functioning. The occurrence of surgical site infections (SSI) represents a significant threat to the efficacy of osteosynthesis procedures. As with other traumas and surgical procedures, the secretion of inflammatory mediators is markedly elevated in this cohort of patients following surgery. Naringenin is one of the most prevalent flavonoids, occurring naturally in grapefruit and other citrus fruits. In vitro studies have demonstrated that naringenin may stimulate the release of osteogenic cytokines and suppress the production of pro-inflammatory factors, which can result in a reduction in bone resorption. Based on these findings, naringenin may prove an effective agent for accelerating the rate of fusion and controlling inflammation. Furthermore, it may enhance quality of life and augment functional activity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Candidate for orthopedic surgery for bone fractures of the lower limbs,

Ambulatory without assistance for a minimum of two months prior to the fracture.

Not having undergone amputation of the lower limbs.

Not suffering from liver cirrhosis.

Disqualifiers

Allergy or intolerant reaction to narangenin capsules

Any abnormal changes in their liver, kidneys tests,

Failure to consume more than 10% of their capsules

Trial design

Design model

Parallel

Treatments tested in this trial

  • The daily ingestion of capsules containing naringenin

    Dietary supplement

    Following surgical intervention, patients will be administered two capsules (equivalent to 500 mg) daily for a period of 14 days. Subsequently, patients will ingest the maintenance dose of 250 mg per day until the 90th day post-surgery.

  • Placebo

    Dietary supplement

    The daily ingestion of capsules containing placebo

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: NaringeninExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 0 interventions

Trial outcomes

Primary outcomes

1

Circulating inflammatory markers

Plasma or serun inflammatory merkers including c-reactive protein and pentraxin 3

Time frame
Baseline, 14 days post-surgery, and 90 days post-surgery.

Secondary outcomes

1

The rate of bone fusion

Time frame
Baseline, 14 days post-surgery, and 90 days post-surgery.
2

Oswestry disability index

Time frame
Baseline, 14 days post-surgery, and 90 days post-surgery.

Other outcomes

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