NCT01102205

Brief Summary

Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of levothyroxine therapy on oxidative balance are also not known in hashimoto disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 13, 2013

Status Verified

June 1, 2013

Enrollment Period

Same day

First QC Date

April 9, 2010

Last Update Submit

June 11, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Poxidative stress markers

    After levotren therapy

Study Arms (3)

healthy

euthyroid hashimoto

hypothyroid hashimoto

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy control.

You may qualify if:

  • age more than 18 years

You may not qualify if:

  • inability to give a written consent
  • other conditions and drug usage affect oxidative stress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakif Gureba Training and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

after overnight fasting state,venous blood will be taken to obtain serum.speciemens stored -70 cantigrade celcius untillanalysing.

MeSH Terms

Conditions

Hashimoto Disease

Condition Hierarchy (Ancestors)

Thyroiditis, AutoimmuneThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mehmet ali Cikrikcioglu, MD

    vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vakif Gureba TRH

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 13, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2010

Study Completion

October 1, 2010

Last Updated

June 13, 2013

Record last verified: 2013-06

Locations