Naringenin Supplementation in Bone Fracture Patients

NCT06612762 | Recruiting

• 1 other identifier: 43008307
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Fractures

Outcome Measures

Primary Outcomes (1)

• Circulating inflammatory markers

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

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

Secondary Outcomes (2)

• The rate of bone fusion

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

• Oswestry disability index

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

Study Arms (2)

Naringenin

EXPERIMENTAL

The daily ingestion of capsules containing naringenin

Dietary Supplement: The daily ingestion of capsules containing naringenin

Control

PLACEBO COMPARATOR

Patients will receive placebo capsules

Interventions

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.

Naringenin

Placebo DIETARY_SUPPLEMENT

The daily ingestion of capsules containing placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ayatollah Taleghani Educational Hospital

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Faeze Gohari, M.S.

CONTACT

2122077424; gouhari71nutr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: November 3, 2024
• Primary Completion (Estimated): May 19, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)