Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 40 for:    "Hashimoto thyroiditis" OR "Hashimoto Disease"

Oxidative Status in Children With Autoimmune Thyroiditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318160
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
Khaled Saad, Assiut University

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
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.


Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 64 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Oxidative Status in Children and Adolescents With Autoimmune Thyroiditis: A Tertiary Center Study From Upper Egypt
Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Oxidative status [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Khaled Saad, Associate professor of Pediatrics, Faculty of medicine,, Assiut University
ClinicalTrials.gov Identifier: NCT02318160     History of Changes
Other Study ID Numbers: AST123-2014
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: December 17, 2014
Last Verified: December 2014
Keywords provided by Khaled Saad, Assiut University:
Autoimmune Thyroiditis
Oxidative Status
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroiditis
Thyroiditis, Autoimmune
Hashimoto Disease
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases