RecruitingNot ApplicableNCT06612762

Naringenin Supplementation in Bone Fracture Patients

Effect of Naringenin Supplementation on the Speed of Bone Fusion and the Concentration of Plasma Inflammatory Factors in Patients With Bone Fractures.


Sponsor

Shahid Beheshti University of Medical Sciences

Enrollment

70 participants

Start Date

Nov 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria6

  • 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.
  • Not suffering from advanced kidney failure (blood creatinine higher than 1.4 mg/dL).
  • Not having metastatic cancer, any chronic inflammatory diseases, nor taking any drugs that affect bone metabolism, including calcitonin, bisphosphonates, and corticosteroids.

Exclusion Criteria3

  • Allergy or intolerant reaction to narangenin capsules
  • Any abnormal changes in their liver, kidneys tests,
  • Failure to consume more than 10% of their capsules

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTThe daily ingestion of capsules containing naringenin

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.

DIETARY_SUPPLEMENTPlacebo

The daily ingestion of capsules containing placebo


Locations(1)

Ayatollah Taleghani Educational Hospital

Tehran, Iran

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06612762


Related Trials