NCT05451472

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

June 20, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

June 20, 2022

Last Update Submit

July 6, 2022

Conditions

Outcome Measures

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

    6 months

Study Arms (1)

pediatric group

EXPERIMENTAL
Diagnostic Test: thyroid function testsDiagnostic Test: complete blood countDiagnostic Test: serum creatinineDiagnostic Test: blood ureaDiagnostic Test: serum electrolyteDiagnostic Test: serum calciumDiagnostic Test: serum phosphorusDiagnostic Test: parathyroid hormone levelDiagnostic Test: liver function testDiagnostic Test: arterial blood gasesDiagnostic Test: complete urine analysis

Interventions

thyroid function testsDIAGNOSTIC_TEST

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

pediatric group
complete blood countDIAGNOSTIC_TEST

complete blood count

pediatric group
serum creatinineDIAGNOSTIC_TEST

serum creatinine

pediatric group
blood ureaDIAGNOSTIC_TEST

blood urea

pediatric group
serum electrolyteDIAGNOSTIC_TEST

serum electrolyte

pediatric group
serum calciumDIAGNOSTIC_TEST

serum calcium

pediatric group
serum phosphorusDIAGNOSTIC_TEST

serum phosphorus

pediatric group

parathyroid hormone level

pediatric group
liver function testDIAGNOSTIC_TEST

ALT\_AST\_Total biliruin\_total protein \_serum albumin

pediatric group
arterial blood gasesDIAGNOSTIC_TEST

PH\_PCO2\_PO2\_HCO3\_base deficit

pediatric group

complete urine analysis

pediatric group

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31013508BACKGROUND
  • 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.

    PMID: 30152421BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Thyroid Function TestsBlood Cell CountBlood Urea NitrogenLiver Function TestsBlood Gas Analysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, EndocrineDiagnostic Techniques and ProceduresDiagnosisCell CountCytological TechniquesClinical Laboratory TechniquesHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaBlood Chemical AnalysisClinical Chemistry TestsKidney Function TestsDiagnostic Techniques, UrologicalDiagnostic Techniques, Digestive SystemRespiratory Function TestsDiagnostic Techniques, Respiratory System

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at pediatric department

Study Record Dates

First Submitted

June 20, 2022

First Posted

July 11, 2022

Study Start

July 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

July 11, 2022

Record last verified: 2022-07