NCT01884649

Brief Summary

Fetuin-A levels are reported to be low as a negative acute phase reactant in systemical inflammatory situations. Hashimoto thyroiditis is characterized with inflammation. In this study, we hypothesised that the serum fetuin A levels could be found to be low due to inflammation in patients with Hashimoto thyroiditis

Trial Health

100
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

June 17, 2013

Last Update Submit

June 21, 2013

Conditions

Keywords

Acute phase reactant, fetuin A, Hashimoto thyroiditis

Outcome Measures

Primary Outcomes (1)

  • Comparison of serum fetuin A levels between patients with Hashimoto thyroiditis and healthy subjects

    1 day (The blood samples were obtained on the same day participants arrived to outpatient clinics.)

Study Arms (2)

Group of Hashimoto thyroiditis patients

Healty control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients ≥ 20 years of age being followed up at the outpatient clinics of the Internal Medicine Department in Medeniyet University Goztepe Training and Research Hospital and fulfilling the below mentioned criteria were included in the study

You may qualify if:

  • patients newly diagnosed with Hashimoto thyroiditis

You may not qualify if:

  • Acute infection
  • Acute or chronic inflammatory disease
  • Anti-inflammatory treatment (non-steroidal anti-inflammatory, corticosteroids etc.)
  • Hypoxic situations (chronic obstructive pulmonary disease etc.)
  • Severe heart, kidney and liver disease
  • Pregnancy
  • Endocrine disorders
  • Malignancy
  • Usage of drug that affects thyroid hormone levels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hashimoto Disease

Condition Hierarchy (Ancestors)

Thyroiditis, AutoimmuneThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 24, 2013

Study Start

May 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

June 24, 2013

Record last verified: 2013-06