NCT04206462

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

December 18, 2019

Last Update Submit

December 20, 2019

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • serum concentration of oxidative stress markers

    oxidated glutathione/reduced glutathion, catalase enzyme, superoxide dismutase, glutathion peroxidase, malonyldialdehyde

    baseline

Study Arms (1)

Osteoarthritis

Questionnaire of eating habits, markers of oxidative stress

Other: Questionnaire of eating habits

Interventions

Questionnaire of eating habitsOTHER

frequency and type of aliments

Osteoarthritis

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with osteoarthritis

You may qualify if:

  • osteoarthritis
  • signed informed consent

You may not qualify if:

  • drugs or foods with antioxidant effects
  • lack of judgement
  • refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Rehabilitation Hospital

Cluj-Napoca, Romania

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Rodica A Ungur, MD, PhD

    University of Medicine and Pharmacy Iuliu Hatieganu

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodica A Ungur, MD, PhD

CONTACT

0040507021rodica.ana.ungur@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 20, 2019

Study Start

July 17, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations

RO(1)