Oxidative Status in Children With Autoimmune Thyroiditis

Autoimmune Thyroiditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318160
• Other study ID #: AST123-2014
• Status: Completed
• Phase: N/A
• First received: December 11, 2014
• Last updated: December 12, 2014
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Hashimoto Disease
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Other:
• measurement of oxidant status in AIT
measurement of thyroid-stimulating hormone (TSH) and free thyroxin (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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxidative status	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	3 months	Yes