- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206462
Investigation of Oxidative Markers and Antioxidant Defense in Female Patients With Osteoarthritis
December 20, 2019 updated by: Rodica Ana Ungur, Iuliu Hatieganu University of Medicine and Pharmacy
Osteoarthritis has a multifactorial etiology: aging, genetic, sex, weight, alimentation, injuries, infections etc.
The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats).
Also, the oxidative-antioxidative balance will be evaluated by determining markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
A total of 300 patients with osteoarthritis will be included in the study.
The objective of the study is to investigate the eating behaviour of the patients included in the study by using a semiquantitative questionnaire (frequency and quantity) by estimating the foods that are known to be protective for osteoarthritis (vegetables, fruits, cereals) as the ones that are considered risk factors (meat origin, refined fats).
Also, the weight and height of each patient will be assessed and the patients will be included in 4 classes based on the body mass index: underweight, normal weight, overweight and obese.
The type of physical activity will also be noted and the oxidative-antioxidative balance will be evaluated by determining serum markers: oxidated glutathione/reducted glutathione, catalase enzyme, superoxide dismutase, glutathion peroxidase and malonyldialdehyde.
Correlation between eating behaviour, body mass index and oxidative stress markers will be made.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rodica A Ungur, MD, PhD
- Phone Number: 159 0040507021
- Email: rodica.ana.ungur@gmail.com
Study Locations
-
-
-
Cluj Napoca, Romania
- Recruiting
- Clinical Rehabilitation Hospital
-
Contact:
- Rodica A Ungur
- Phone Number: 159 0040207021
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
patients with osteoarthritis
Description
Inclusion Criteria:
- osteoarthritis
- signed informed consent
Exclusion Criteria:
- drugs or foods with antioxidant effects
- lack of judgement
- refuse to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Osteoarthritis
Questionnaire of eating habits, markers of oxidative stress
|
frequency and type of aliments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum concentration of oxidative stress markers
Time Frame: baseline
|
oxidated glutathione/reduced glutathion, catalase enzyme, superoxide dismutase, glutathion peroxidase, malonyldialdehyde
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rodica A Ungur, MD, PhD, University of Medicine and Pharmacy Iuliu Hatieganu
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 17, 2019
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
December 18, 2019
First Submitted That Met QC Criteria
December 18, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
December 24, 2019
Last Update Submitted That Met QC Criteria
December 20, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversitateaIH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Questionnaire of eating habits
-
Istanbul Medeniyet UniversityCompletedHealth Knowledge, Attitudes, Practice | Eating HabitTurkey
-
University Hospital, Clermont-FerrandRecruiting
-
University of DundeeUniversity of St AndrewsCompletedCardiovascular Risk
-
Ege UniversityRecruitingBody Image | Eating Behavior | Nutrition, Healthy | Eating Habit | Nutrition Disorders in AdolescenceTurkey
-
Karolinska InstitutetCompletedType 2 Diabetes Mellitus | Dietary HabitsSweden
-
Universidad Católica de ÁvilaCompletedQuality of Life | Physical InactivitySpain
-
Instituto Tecnologico y de Estudios Superiores...CompletedObesity | OverweightMexico
-
Wissenschaftliches Institut Bethanien e.VCompletedTravel, Sleep Related Disorder
-
Association for Innovation and Biomedical Research...CompletedAge Related Macular DegenerationPortugal
-
Hospices Civils de LyonCompletedHyperalimentation and ObesityFrance