NCT06612762 Naringenin Supplementation in Bone Fracture Patients
| NCT ID | NCT06612762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shahid Beheshti University of Medical Sciences |
| Condition | Bone Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-11-03 |
| Primary Completion | 2026-05-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-11-03 with a primary completion date of 2026-05-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Allergy or intolerant reaction to narangenin capsules * Any abnormal changes in their liver, kidneys tests, * Failure to consume more than 10% of their capsules
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06612762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Bone Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06612762 currently recruiting?
Yes, NCT06612762 is actively recruiting participants. Contact the research team at gouhari71nutr@gmail.com for enrollment information.
Where is the NCT06612762 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT06612762 clinical trial?
NCT06612762 is sponsored by Shahid Beheshti University of Medical Sciences. The trial plans to enroll 70 participants.