Evaluation of Oxidative Stress and Effect of Levothyroxin... | NCT01102205

Studies
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease

NCT01102205

Sponsor

Vakif Gureba Training and Research Hospital

Status

Completed

Last Update Posted

Jun 13, 2013Estimated

Enrollment

130Actual

Phase

Not provided

Conditions

Hashimoto Disease

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Apr 9, 2010

First Submission Date that Met QC Criteria

Apr 12, 2010

First Posted Date

Apr 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2013

Last Update Posted Date

Jun 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mehmet Ali Cikrikcioglu, Vakif Gureba TRH, Vakif Gureba Training and Research HospitalPrincipal Investigator

Lead Sponsor

Vakif Gureba Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1 PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be repeated except PON1 phenotyping.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

130Actual

Measure	Description	Time Frame
Poxidative stress markers		After levotren therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age more than 18 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehmet ali Cikrikcioglu, MD	vakif gureba TRH,fatih,istanbul,turkey.specialist in internal medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vakif Gureba Training and Research Hospital		Istanbul		34100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D050031	Hashimoto Disease

Ancestor Terms

ID	Term
D013967	Thyroiditis, Autoimmune
D013966	Thyroiditis
D013959	Thyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
healthy
euthyroid hashimoto
hypothyroid hashimoto