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Status unknownNCT05451472Updated Jul 11, 2022

Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital

An interventional study of thyroid function tests and complete blood count in Chronic Renal Failure, sponsored by Sohag University. Status unknown. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2022-07-11.

Sponsored by Sohag University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
2 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 39 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with known thyroid disease. Patients with a history of autoimmune disease .
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (estimated)

Study arms

  • Experimental
    pediatric group

    Diagnostic Test: thyroid function tests · Diagnostic Test: complete blood count · Diagnostic Test: serum creatinine · Diagnostic Test: blood urea · Diagnostic Test: serum electrolyte · Diagnostic Test: serum calcium · Diagnostic Test: serum phosphorus · Diagnostic Test: parathyroid hormone level · Diagnostic Test: liver function test · Diagnostic Test: arterial blood gases · Diagnostic Test: complete urine analysis

Interventions

  • Diagnostic testthyroid function tests

    Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)

  • Diagnostic testcomplete blood count

    complete blood count

  • Diagnostic testserum creatinine

    serum creatinine

  • Diagnostic testblood urea

    blood urea

  • Diagnostic testserum electrolyte

    serum electrolyte

  • Diagnostic testserum calcium

    serum calcium

  • Diagnostic testserum phosphorus

    serum phosphorus

  • Diagnostic testparathyroid hormone level

    parathyroid hormone level

  • Diagnostic testliver function test

    ALT_AST_Total biliruin_total protein _serum albumin

  • Diagnostic testarterial blood gases

    PH_PCO2_PO2_HCO3_base deficit

  • Diagnostic testcomplete urine analysis

    complete urine analysis

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31013508 ↗
  • 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. PubMed 30152421 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05451472
Lead sponsor
Sohag University
Responsible party
Michael Rafat Helmi (resident doctor at pediatric department, Sohag University) — Principal investigator
First posted
Jul 11, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Jul 11, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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