Chronic Renal FailureNCT05451472
Evluation of Thyroid Functions in Hemodialysis Childern in Sohag University Hospital
A study testing thyroid function tests, complete blood count and serum creatinine in people with Chronic Renal Failure, run by Sohag University.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- thyroid function tests, complete blood count and serum creatinine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study.
Who cannot join
- Patients with known thyroid disease. Patients with a history of autoimmune disease .
About this study
Official title: Evalution of Thyroid Functions in Hemodialysis Children in Sohag University Hospital
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.
Read more
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.
- Conditions
- Chronic Renal Failure
- Being tested
- thyroid function tests, complete blood count, serum creatinine, blood urea, serum electrolyte
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroid function testsDiagnostic test
Thyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3)
complete blood countDiagnostic test
complete blood count
serum creatinineDiagnostic test
serum creatinine
blood ureaDiagnostic test
blood urea
serum electrolyteDiagnostic test
serum electrolyte
serum calciumDiagnostic test
serum calcium
serum phosphorusDiagnostic test
serum phosphorus
parathyroid hormone levelDiagnostic test
parathyroid hormone level
liver function testDiagnostic test
ALT_AST_Total biliruin_total protein _serum albumin
arterial blood gasesDiagnostic test
PH_PCO2_PO2_HCO3_base deficit
complete urine analysisDiagnostic test
complete urine analysis
| Study group | Role | What they receive |
|---|---|---|
| pediatric group | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rafat Helmi, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451472
- Sponsor's protocol ID
- soh-22-06-09
- Status last verified
- Jul 2022
- First submitted
- 20 Jun 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 31013508Naseem 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evalution of Thyroid Functions in Hemodialysis Children in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT05451472
- Acronym / sponsor ID
- soh-22-06-09
- Conditions
- Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric group | Experimental | 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 |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children started hemodialysis for end stage renal disease at age of 2 to 16 years will be included in the study.
Key exclusion criteria (1 listed)
- Patients with known thyroid disease. Patients with a history of autoimmune disease .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroid function testsThyroid function tests:thyroid stimulating hormone (TSH), total thyroxine (T4), free thyroxine (FT4), total triiodothyronine (T3), and free triiodothyronine (FT3) | Diagnostic test | pediatric group |
| complete blood countcomplete blood count | Diagnostic test | pediatric group |
| serum creatinineserum creatinine | Diagnostic test | pediatric group |
| blood ureablood urea | Diagnostic test | pediatric group |
| serum electrolyteserum electrolyte | Diagnostic test | pediatric group |
| serum calciumserum calcium | Diagnostic test | pediatric group |
| serum phosphorusserum phosphorus | Diagnostic test | pediatric group |
| parathyroid hormone levelparathyroid hormone level | Diagnostic test | pediatric group |
| liver function testALT_AST_Total biliruin_total protein _serum albumin | Diagnostic test | pediatric group |
| arterial blood gasesPH_PCO2_PO2_HCO3_base deficit | Diagnostic test | pediatric group |
| complete urine analysiscomplete urine analysis | Diagnostic test | pediatric group |
Primary outcome
Detection of thyroid function in hemodialysis childern
Time frame: 6 months
Detection of decrease thyroid function(T3_T4_TSH) in hemodialysis childern Detection of increase thyroid function(T3_T4_TSH) in hemodialysis childern
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 31013508Pan 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.
- Background: PubMed 30152421Naseem 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing thyroid function tests, complete blood count and serum creatinine in people with Chronic Renal Failure, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of thyroid function in hemodialysis childern (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451472, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.