NCT02318160

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

2 months

First QC Date

December 11, 2014

Last Update Submit

December 12, 2014

Conditions

Keywords

Autoimmune ThyroiditisOxidative StatusChildren

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Thyroiditis, Autoimmune

Condition Hierarchy (Ancestors)

ThyroiditisThyroid DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Pediatrics, Faculty of medicine,

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 17, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 17, 2014

Record last verified: 2014-12