Evidence map›Paper›PMID 39695828›Full record

ArticleTrials2024

Effects of trehalose on bone healing, physical function, and pain in patients with pertrochanteric fractures: a randomized controlled trial protocol.

Reza Zandi, Hosna Omidi Razani, Amir Mehrvar, Mohammad-Reza Jowshan, Amirhossein Sahebkar, Bahar Nikooyeh, Hoda Zahedi, Shahin Talebi

Erratum issuedAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Reza ZandiMusculoskeletal Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hosna Omidi RazaniStudent Research Committee, Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Amir MehrvarMusculoskeletal Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad-Reza JowshanDepartment of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.
Amirhossein SahebkarCenter for Global Health Research, Saveetha Medical College and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, India.
Bahar NikooyehDepartment of Nutrition Research, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hoda ZahediDepartment of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition and Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hoda.s.zahedi@gmail.com.ORCID http://orcid.org/0000-0003-4431-7459
Shahin TalebiMusculoskeletal Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. sh.talebi1365@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAppropriate management of fractures is crucial for restoring natural bone function and preventing long-term complications. Previous research on animal models indicates that trehalose can improve bone fracture healing by inhibiting the inflammatory cascade. We hope that trehalose can accelerate bone fracture healing in humans, alleviate pain, and ultimately enhance the individual's quality of life.

methodsThis randomized, double-blind clinical trial will be conducted at Taleghani Hospital in Tehran, Iran. Sixty-four patients admitted to the orthopedic ward will be enrolled based on eligibility criteria. The participants will be randomly allocated based on the permuted block randomization into two groups: those receiving trehalose (32 patients) or placebo (32 patients). The patients in the trehalose and placebo groups will receive 3.3 g of trehalose or placebo for 12 weeks, respectively. A consent form, general questionnaire, as well as the Visual Analog Scale (VAS), Harris Hip Score (HHS), and radiological analyses will be used to assess fracture healing quality. The intention-to-treat principle will form the basis of the statistical analysis. DISCUSSION: The trial results may provide a convenient and safe adjuvant treatment option for the Pertrochanteric Fractures population.

trial registrationIranian Registry of Clinical Trials. IRCT20240605062013N1. URL of the trial registry record: https://irct.behdasht.gov.ir/trial/77212 . Registration date: 16 June 2024.

Indexed as

Fracture HealingHip FracturesRandomized Controlled Trials as TopicTrehaloseAgedDouble-Blind MethodFemaleHumansIranMaleMiddle AgedPain MeasurementQuality of LifeRecovery of FunctionTime FactorsTreatment OutcomeTrehaloseBone fractureNutritional supplementPainPertrochanteric fracturesTrehalose

Identifiers

PMID39695828
PMCPMC11653555

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.