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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05451472
Other study ID # soh-22-06-09
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date January 1, 2023

Study information

Verified date July 2022
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thyroid gland and its hormones play an important role in organ development and the homeostatic control of many physiological mechanisms such as body growth and energy expenditure. The two main thyroid hormones are triiodothyronine (T3) and thyroxine (T4) affect renal development and metabolism so any impairment in thyroid functions lead to or aggravate kidney diseases. On the other hand, kidneys play an important role in the thyroid metabolism as it normally contributes to the clearance of iodide, primarily by glomerular filtration. Among patients with renal failure, there is diminished iodide excretion and an increase in plasma inorganic iodide, which results in increased uptake of the iodide by the thyroid gland. Increases in total body inorganic iodide can potentially block thyroid hormone production (the Wolff-Chaik off effect). Such a change may explain the slightly higher frequency of goiter and hypothyroidism in patients with chronic kidney diseases. The kidneys affect the hypothalamic pituitary-thyroid axis, so any impairment in kidney functions leads to disturbed thyroid physiology. All levels of the hypothalamic-pituitary-thyroid axis may be involved, including alterations in hormone production, distribution, and excretion. End stage renal disease (ESRD) and hemodialysis (HD) affect the levels of all thyroid hormones. The earliest and the most common thyroid function abnormality in patients with ESRD on HD is low T3 level (especially total T3 than free T3). This is called 'low T3 syndrome. The prevalence of subclinical hypothyroidism has been reported to be much higher in patients with ESRD on HD than in the general population. Due to similarity of signs and symptoms, sometimes it is difficult to identify subjects with ESRD also has hypothyroidism; therefore, different studies have been carried out to establish the incidence of these conditions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date January 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria: - Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study. Exclusion Criteria: - Patients with known thyroid disease. Patients with a history of autoimmune disease .

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
thyroid function tests
Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)
complete blood count
complete blood count
serum creatinine
serum creatinine
blood urea
blood urea
serum electrolyte
serum electrolyte
serum calcium
serum calcium
serum phosphorus
serum phosphorus
parathyroid hormone level
parathyroid hormone level
liver function test
ALT_AST_Total biliruin_total protein _serum albumin
arterial blood gases
PH_PCO2_PO2_HCO3_base deficit
complete urine analysis
complete urine analysis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

References & Publications (2)

Naseem F, Mannan A, Dhrolia MF, Imtiaz S, Qureshi R, Ahmed A. Prevalence of subclinical hypothyroidism in patients with chronic kidney disease on maintenance hemodialysis. Saudi J Kidney Dis Transpl. 2018 Jul-Aug;29(4):846-851. doi: 10.4103/1319-2442.239646. — View Citation

Pan B, Du X, Zhang H, Hua X, Wan X, Cao C. Relationships of Chronic Kidney Disease and Thyroid Dysfunction in Non-Dialysis Patients: A Pilot Study. Kidney Blood Press Res. 2019;44(2):170-178. doi: 10.1159/000499201. Epub 2019 Apr 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of thyroid function in hemodialysis childern Detection of decrease thyroid function(T3_T4_TSH) in hemodialysis childern Detection of increase thyroid function(T3_T4_TSH) in hemodialysis childern 6 months
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