Bone FracturesNCT06612762
Naringenin Supplementation in Bone Fracture Patients
A study testing The daily ingestion of capsules containing naringenin in people with Bone Fractures, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bone Fractures
- What is being tested?
- The daily ingestion of capsules containing naringenin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- 3 Nov 2024to 2 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Ayatollah Taleghani Educational Hospital
Tehran
Faeze Gohari, Ms.C., +98 9155073603, gouhari71nutr@gmail.com
About this study
Official title: Effect of Naringenin Supplementation on the Speed of Bone Fusion and the Concentration of Plasma Inflammatory Factors in Patients With Bone Fractures.
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.
Read the detailed description
The study subjects will be selected from among the patients with bone fractures of the lower limbs who are hospitalized in the orthopedic department of Ayatollah Taleghani University Hospital in Tehran. The following criteria will be used to determine which patients are eligible for inclusion in the study:
Inclusion criteria: patients aged 18 to 60 years, candidates 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. Additionally, subjects must not have any chronic inflammatory diseases, nor must they be taking any drugs that affect bone metabolism, including calcitonin, bisphosphonates, and corticosteroids. Furthermore, subjects must not be taking any anti-inflammatory drugs.
Subjects will be excluded from the study if they experience an allergic or intolerant reaction to Narangenin capsules, if there are any abnormal changes in their liver, kidneys tests, or if they fail to consume more than 10% of their capsules in weekly monitoring.
Subjects will be randomly assigned to one of two intervention groups (Narangenin capsules) or a control group receiving a placebo. Patient assignment will be conducted using the stratified permuted block randomization method. Patients will be randomly assigned to one of two intervention groups (narangenin capsules) or a control group (placebo) based on their history of diabetes. Each stratum will consist of four cases, with two cases assigned to the placebo group and two cases assigned to the naringenin group. To ensure the blinding of the study, the capsules will be identical in appearance and packaged in the same containers. Each capsule of the intervention group will contain 250 mg of naringenin, while each capsule of the control group will contain 250 mg of starch. The capsules are administered to the patients by the nursing staff, who are unaware of the patient grouping. The supplementation regimen will commence one day following surgery, with participating patients receiving two capsules (equivalent to 500 mg) daily for 14 days. Subsequently, following a 14-day period, the patients will resume the maintenance dose of 250 mg per day until the 90th day post-surgery. During the intervention period, patients will be monitored for regular use of the capsules and any adverse reactions. Patients will be required to attend the hospital\'s orthopedic clinic on two occasions: 14 days after surgery and three months after surgery. During these visits, fasting blood samples will be taken for biochemical tests. The fusion status of patients will be evaluated by radiography after surgery, 14 days, and three months after surgery. Additionally, functional testing (Oswestry disability index (ODI)) will be performed two weeks and three months after surgery.
- Conditions
- Bone Fractures
- Being tested
- The daily ingestion of capsules containing naringenin, Placebo
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The daily ingestion of capsules containing naringeninDietary 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.
PlaceboDietary supplement
The daily ingestion of capsules containing placebo
| Study group | Role | What they receive |
|---|---|---|
| Naringenin | Experimental | The daily ingestion of capsules containing naringenin Receives: Dietary Supplement: The daily ingestion of capsules containing naringenin |
| Control | Placebo comparator | Patients will receive placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating inflammatory markers
Plasma or serun inflammatory merkers including c-reactive protein and pentraxin 3
Measured: Baseline, 14 days post-surgery, and 90 days post-surgery.
Secondary outcomes (2)
The rate of bone fusion
Measured: Baseline, 14 days post-surgery, and 90 days post-surgery.
Oswestry disability index
Measured: Baseline, 14 days post-surgery, and 90 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start3 Nov 2024
- Primary completion19 Oct 2026 (estimated)
- Study completion2 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612762
- Sponsor's protocol ID
- 43008307
- Status last verified
- Feb 2026
- First submitted
- 22 Sep 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Naringenin Supplementation on the Speed of Bone Fusion and the Concentration of Plasma Inflammatory Factors in Patients With Bone Fractures.
- ClinicalTrials.gov ID
- NCT06612762
- Acronym / sponsor ID
- 43008307
- Conditions
- Bone Fractures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 2 Nov 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study subjects will be selected from among the patients with bone fractures of the lower limbs who are hospitalized in the orthopedic department of Ayatollah Taleghani University Hospital in Tehran. The following criteria will be used to determine which patients are eligible for inclusion in the study:
Inclusion criteria: patients aged 18 to 60 years, candidates 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. Additionally, subjects must not have any chronic inflammatory diseases, nor must they be taking any drugs that affect bone metabolism, including calcitonin, bisphosphonates, and corticosteroids. Furthermore, subjects must not be taking any anti-inflammatory drugs.
Subjects will be excluded from the study if they experience an allergic or intolerant reaction to Narangenin capsules, if there are any abnormal changes in their liver, kidneys tests, or if they fail to consume more than 10% of their capsules in weekly monitoring.
Subjects will be randomly assigned to one of two intervention groups (Narangenin capsules) or a control group receiving a placebo. Patient assignment will be conducted using the stratified permuted block randomization method. Patients will be randomly assigned to one of two intervention groups (narangenin capsules) or a control group (placebo) based on their history of diabetes. Each stratum will consist of four cases, with two cases assigned to the placebo group and two cases assigned to the naringenin group. To ensure the blinding of the study, the capsules will be identical in appearance and packaged in the same containers. Each capsule of the intervention group will contain 250 mg of naringenin, while each capsule of the control group will contain 250 mg of starch. The capsules are administered to the patients by the nursing staff, who are unaware of the patient grouping. The supplementation regimen will commence one day following surgery, with participating patients receiving two capsules (equivalent to 500 mg) daily for 14 days. Subsequently, following a 14-day period, the patients will resume the maintenance dose of 250 mg per day until the 90th day post-surgery. During the intervention period, patients will be monitored for regular use of the capsules and any adverse reactions. Patients will be required to attend the hospital\'s orthopedic clinic on two occasions: 14 days after surgery and three months after surgery. During these visits, fasting blood samples will be taken for biochemical tests. The fusion status of patients will be evaluated by radiography after surgery, 14 days, and three months after surgery. Additionally, functional testing (Oswestry disability index (ODI)) will be performed two weeks and three months after surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naringenin | Experimental | Dietary Supplement: The daily ingestion of capsules containing naringeninThe daily ingestion of capsules containing naringenin |
| Control | Placebo comparator | –Patients will receive placebo capsules |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- Allergy or intolerant reaction to narangenin capsules
- Any abnormal changes in their liver, kidneys tests,
- Failure to consume more than 10% of their capsules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The daily ingestion of capsules containing naringeninFollowing 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 supplement | Naringenin |
| PlaceboThe daily ingestion of capsules containing placebo | Dietary supplement | – |
Primary outcome
Circulating inflammatory markers
Time frame: Baseline, 14 days post-surgery, and 90 days post-surgery.
Plasma or serun inflammatory merkers including c-reactive protein and pentraxin 3
2 secondary outcomes
The rate of bone fusion
Time frame: Baseline, 14 days post-surgery, and 90 days post-surgery.
Oswestry disability index
Time frame: Baseline, 14 days post-surgery, and 90 days post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The daily ingestion of capsules containing naringenin in people with Bone Fractures, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faeze Gohari, M.S. (2122077424, gouhari71nutr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating inflammatory markers (time frame: Baseline, 14 days post-surgery, and 90 days post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.