Oxidative Status in Children With Autoimmune Thyroiditis

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02318160

Collaborator

(none)

Enrollment

1.9

Duration (Months)

Study Details

Study Description

Brief Summary

Oxidative status in autoimmune thyroiditis was not investigated previously in children and adolescents. We investigated oxidant and antioxidant systems in a cohort of Egyptian children and adolescents with AIT to explore their relation with biomarkers of autoimmunity and thyroid function.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Thyroiditis	Other: measurement of oxidant status in AIT

Detailed Description

Methods: A case control study included 32 children with autoimmune thyroiditis and 32 healthy subjects with matching age and sex were included as a control group. Thorough history, examination, thyroid ultrasound, measurement of thyroid-stimulating hormone (TSH) and free thyroxine (FT4), as well as anti-thyroid peroxidase antibodies (TPOAb) and anti-thyroglobulin antibody (TgAb) were done in addition to assessment of malondialdehyde (MDA) and total antioxidant capacity (TAC) levels as an oxidative stress markers. Results: Overt hypothyroidism was detected in 23/32 while subclinical hypothyroidism was detected in 9/32 of the studied patients. Malondialdehyde levels were significantly elevated while total antioxidant capacity levels were significantly decreased in autoimmune thyroiditis patients compared with healthy controls. The difference was more evident in patients with overt hypothyroidism than those with subclinical hypothyroidism. We also observed a significant positive correlation between anti-thyroid peroxidase antibodies levels and age, TSH, malondialdehyde, thyroid volume and a negative correlation with total antioxidant capacity and thyroxine .

Conclusions: The high serum malondialdehyde and lower total antioxidant capacity levels in patients with autoimmune thyroiditis and the correlation of thyroid antibodies with biomarkers of oxidative stress may reflect the role of autoimmunity in the development of oxidative stress. Future studies are needed for evaluation of the antioxidant therapy for autoimmune thyroiditis patients.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

64 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Oxidative Status in Children and Adolescents With Autoimmune Thyroiditis: A Tertiary Center Study From Upper Egypt

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

Oxidative status [3 months]
measurement of thyroid-stimulating hormone (TSH) and free thyroxine (FT4), as well as anti-thyroid peroxidase antibodies (TPOAb) and anti-thyroglobulin antibody (TgAb) were done in addition to assessment of malondialdehyde (MDA) and total antioxidant capacity (TAC) levels as an oxidative stress markers

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Newly diagnosed AIT.
Age >6 years <18 years.
Iodine sufficient region.

Exclusion Criteria:

Children on antioxidants or antithyroid drugs
Cardiac, renal and hepatic disease.
Children with other autoimmune and collagen diseases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Khaled Saad, Associate professor of Pediatrics, Faculty of medicine,, Assiut University

ClinicalTrials.gov Identifier:

NCT02318160

Other Study ID Numbers:

AST123-2014

First Posted:

Dec 17, 2014

Last Update Posted:

Dec 17, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Khaled Saad, Associate professor of Pediatrics, Faculty of medicine,, Assiut University

Autoimmune Thyroiditis

Oxidative Status

Children

Additional relevant MeSH terms:

Thyroiditis

Thyroiditis, Autoimmune

Hashimoto Disease

Study Results

No Results Posted as of Dec 17, 2014