Clinical trial NCT02318160: Oxidative Status in Children With Autoimmune Thyroiditis
Official title: Oxidative Status in Children and Adolescents With Autoimmune Thyroiditis: A Tertiary Center Study From Upper Egypt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Thyroiditis
Keywords: Autoimmune Thyroiditis
Oxidative Status
Children
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our case control study was conducted on 32 children and adolescents with Autoimmune Thyroiditis attending the Pediatric Endocrinology Clinic of Assiut University Children Hospital, Assiut, Egypt. . Diagnosis of Autoimmune Thyroiditis had been made by elevated anti-thyroid peroxidase antibodies (TPO Ab) and/or anti-thyroglobulin antibodies (Tg Ab) as well as typical hypoechogenicity of the thyroid in high-resolution sonography . Another group of 32 age and sex-matched healthy subjects as a control group.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxidative status
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Metwalley KA, Farghaly HS, Saad K, Othman HA. Oxidative status in children and adolescents with autoimmune thyroiditis. Clin Exp Med. 2016 Nov;16(4):571-575. doi: 10.1007/s10238-015-0386-x. Epub 2015 Sep 5.