HypothyroidismNCT04877665
Establishing RIs for TSH in Children Under the Age of Two Years
An observational study of Hypothyroidism, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Reference intervals (RIs) of thyroid-stimulating hormone (TSH) and free thyroxine (FT4) are age, assay and population specific. Currently, the age and assay-specific RIs for TSH are not available for children under two years of age. Read more about this study
- Who is it for?
- Ages 1 month to 24 months
- Conditions the study is for
- Hypothyroidism
- How many people
- 131 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2018to 30 Mar 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 1 month to 24 months
- All sexes
- Child
Study population: Healthy children from 1 to 24 months
Who may be able to join
- Healthy children from 1 to 24 months
Who cannot join
- recent illness, hospitalization, medication and maternal history of thyroid-related diseases, recent abnormal total leucocyte or neutrophil count in the medical record or positive microbial cultures, history of any diagnosed disease or infection, history of hospitalization during the previous four weeks, congenital hypothyroidism or transient congenital hypothyroidism, history of maternal thyroid illness, or any medications with potential influences on the thyroid function, such as amiodarone, anti-epileptic drugs, glucocorticoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing Reference Intervals for Thyroid Stimulating Hormone in Children Under the Age of Two Years
Reference intervals (RIs) of thyroid-stimulating hormone (TSH) and free thyroxine (FT4) are age, assay and population specific. Currently, the age and assay-specific RIs for TSH are not available for children under two years of age. This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.
Read the detailed description
A prospective cross-sectional study was conducted at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH Karachi Pakistan, from August 2018 to March 2019 after approval from The Aga Khan University Ethics Review Committee.
Healthy children from 1 to 24 months visiting the clinical lab for serum vitamin D testing were invited to participate in the study.
Their health status was determined by asking questions related to their medical medical history after informed consent from their parents/guardian. Children with recent abnormal total leucocyte or neutrophil count in the medical record or positive microbial cultures, history of any diagnosed disease or infection, history of hospitalization during the previous four weeks, congenital hypothyroidism or transient congenital hypothyroidism, history of maternal thyroid illness, or any medications with potential influences on the thyroid function, such as amiodarone, anti-epileptic drugs, glucocorticoids were excluded.
The RIs were established using the CLSI, C28-A3 guidelines, using a sample size of at least 120 specimens.
Serum TSH and FT4 were measured on ADVIA Centaur (Siemens Diagnostics, US), using chemiluminescence immunoassay.
The EP evaluator version 10 and SPSS version 21 were used for data analysis. Kolmogorov-Smirnov test assessed the normality of the data.
The RIs based on central 95% of the population were established. The median age of subjects, TSH and FT4 levels were calculated. For assessing differences in the male and female gender, Students' t' test was applied, taking p-value <0.050 as significant. Spearman's test computed the correlation between age, TSH and FT4 levels.
A total of 132 children were included in the study; one subject with confirmed congenital hypothyroidism (CH) was excluded from the study, shown in figure 1. The TSH and FT4 values of 131 subjects were included to establish the RIs. The median (IQR) age of the study subjects was 12 (11) months, and 78 (59.5%) were male.
Reference interval based on central 95% of the population for TSH is 0.73-4.94 µIU/mL and for FT4 is 0.81-1.51 ng/dL.
- Conditions
- Hypothyroidism
- Keywords
- Thyroid Stimulating Hormone, Reference Interval, Children, Pakistan
- Medical subject headings
- Hypothyroidism
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishing Reference Intervals for Thyroid Stimulating Hormone in Children under the age of two years
This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.
Measured: August 2018 to March 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Aug 2018
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothyroidismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 131 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siraj Muneer, Aga Khan University Hospital, Pakistan
- Investigators
- Siraj Muneer, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877665
- Sponsor's protocol ID
- 5255-Pat-ERC-18
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Reference Intervals for Thyroid Stimulating Hormone in Children Under the Age of Two Years
- ClinicalTrials.gov ID
- NCT04877665
- Acronym / sponsor ID
- 5255-Pat-ERC-18
- Conditions
- Hypothyroidism
- Keywords
- Thyroid Stimulating Hormone, Reference Interval, Children, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 7 May 2021 (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.
Reference intervals (RIs) of thyroid-stimulating hormone (TSH) and free thyroxine (FT4) are age, assay and population specific. Currently, the age and assay-specific RIs for TSH are not available for children under two years of age. This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.
Detailed description
A prospective cross-sectional study was conducted at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH Karachi Pakistan, from August 2018 to March 2019 after approval from The Aga Khan University Ethics Review Committee.
Healthy children from 1 to 24 months visiting the clinical lab for serum vitamin D testing were invited to participate in the study.
Their health status was determined by asking questions related to their medical medical history after informed consent from their parents/guardian. Children with recent abnormal total leucocyte or neutrophil count in the medical record or positive microbial cultures, history of any diagnosed disease or infection, history of hospitalization during the previous four weeks, congenital hypothyroidism or transient congenital hypothyroidism, history of maternal thyroid illness, or any medications with potential influences on the thyroid function, such as amiodarone, anti-epileptic drugs, glucocorticoids were excluded.
The RIs were established using the CLSI, C28-A3 guidelines, using a sample size of at least 120 specimens.
Serum TSH and FT4 were measured on ADVIA Centaur (Siemens Diagnostics, US), using chemiluminescence immunoassay.
The EP evaluator version 10 and SPSS version 21 were used for data analysis. Kolmogorov-Smirnov test assessed the normality of the data.
The RIs based on central 95% of the population were established. The median age of subjects, TSH and FT4 levels were calculated. For assessing differences in the male and female gender, Students' t' test was applied, taking p-value <0.050 as significant. Spearman's test computed the correlation between age, TSH and FT4 levels.
A total of 132 children were included in the study; one subject with confirmed congenital hypothyroidism (CH) was excluded from the study, shown in figure 1. The TSH and FT4 values of 131 subjects were included to establish the RIs. The median (IQR) age of the study subjects was 12 (11) months, and 78 (59.5%) were male.
Reference interval based on central 95% of the population for TSH is 0.73-4.94 µIU/mL and for FT4 is 0.81-1.51 ng/dL.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Age groups
- Child
- Study population
- Healthy children from 1 to 24 months
Key inclusion criteria (1 listed)
- Healthy children from 1 to 24 months
Key exclusion criteria (1 listed)
- recent illness, hospitalization, medication and maternal history of thyroid-related diseases, recent abnormal total leucocyte or neutrophil count in the medical record or positive microbial cultures, history of any diagnosed disease or infection, history of hospitalization during the previous four weeks, congenital hypothyroidism or transient congenital hypothyroidism, history of maternal thyroid illness, or any medications with potential influences on the thyroid function, such as amiodarone, anti-epileptic drugs, glucocorticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establishing Reference Intervals for Thyroid Stimulating Hormone in Children under the age of two years
Time frame: August 2018 to March 2019
This study aimed to establish reference intervals for serum concentrations of TSH and FT4 in healthy children aged 1-24 months as per CLSI C28-A3 guidelines.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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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.
Siraj Muneer principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establishing Reference Intervals for Thyroid Stimulating Hormone in Children under the age of two years (time frame: August 2018 to March 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2021.