Evidence map›Paper›PMID 39627130›Full record

ArticleBMJ open2024

Effect of oral trehalose supplementation on inflammation and wound healing in patients with peri-trochanteric fractures: study protocol for a randomised clinical trial.

Reza Zandi, Alireza Tavallaei Zavareh, Amir Mehrvar, Mohammad-Reza Jowshan, Amirhossein Sahebkar, Bahareh Nikooyeh, Hoda Zahedi, Shahin Talebi

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Reza ZandiMusculoskeletal Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Alireza Tavallaei ZavarehStudent Research Committee, Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Amir MehrvarDepartment of Orthopedics, Taleghani Hospital Research Development Committee, School of Medicine, 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 SahebkarBiotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Bahareh NikooyehDepartment of Nutrition Research, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Hoda ZahediDepartment of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran hoda.s.zahedi@gmail.com sh.talebi1365@gmail.com.ORCID http://orcid.org/0000-0003-4431-7459
Shahin TalebiDepartment of Orthopedics, Taleghani Hospital Research Development Committee, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran hoda.s.zahedi@gmail.com sh.talebi1365@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPeri-trochanteric fractures, common among the elderly with osteoporosis, pose significant morbidity and mortality risks. These fractures are increasing due to the ageing population, with Nordic countries seeing a high incidence. They present challenges for orthopaedic surgeons and can lead to functional decline and high medical costs. Hip fractures have severe consequences, including pain, immobility and increased mortality. Managing wound care is complex, involving various healing phases. Trehalose, a disaccharide with antioxidant and anti-inflammatory properties, has shown promise in wound healing and other health conditions. Studies suggest its potential benefits in reducing inflammation and aiding wound healing in peri-trochanteric fracture patients, but more research is needed to confirm its clinical effectiveness in humans. METHODS AND ANALYSIS: The study is a double-blind, placebo-controlled randomised clinical trial aiming to evaluate the effect of trehalose consumption on patients with peri-trochanteric fractures. The study will include 64 patients meeting specific inclusion criteria and will assess inflammatory markers and wound healing at different time points. Patients will be divided into two groups, one receiving trehalose and the other receiving a placebo for 12 weeks. Various measurements and assessments will be conducted, including biochemical assays, wound assessments, anthropometric measurements and dietary intake evaluations. Data analysis will be performed using SPSS software, and statistical tests will be used to compare outcomes between the intervention and control groups. ETHICS AND DISSEMINATION: The Ethics Committee of Shahid Beheshti University of Medical Sciences (IR.SBMU.RETECH.REC.1403.191). TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials. IRCT20180404039188N5. URL of trial registry record: https://irct.behdasht.gov.ir/trial/77572. Registration date: 7 July 2024.

Indexed as

Hip FracturesInflammationRandomized Controlled Trials as TopicTrehaloseWound HealingAdministration, OralAgedDietary SupplementsDouble-Blind MethodFemaleHumansMaleTrehaloseHip fracturesInflammationPeri-trochantericTrehaloseWound healing

Identifiers

PMID39627130
PMCPMC11624808

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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 Socratic graph.