HypothyroidismMyEndo-ThyroidNCT02190214
Thyroid Disorders in Malaysia: A Nationwide Multicentre Study
An observational study of Hypothyroidism and Subclinical Hypothyroidism, run by International Islamic University Malaysia.
Trial summary
This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypothyroidism, Subclinical Hypothyroidism, Hyperthyroidism
- How many people
- 2,498 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Sep 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the time of sampling
Who may be able to join
- Aged equal or more than 18 years old at the time of sampling
- Malaysian citizen
Who cannot join
- Respondents who did not give consent
About this study
Official title: Thyroid Disorders in Malaysian: A Nationwide Multicentre Study
This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population
General hypotheses:
The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population
Read the detailed description
This will be a cross-sectional population based study involving Malaysian adults (aged 18 year old and above). Cluster sampling will be used to select respondents that will be representative of the Malaysian population. Selected respondent will be interviewed, anthropometric measurement taken, blood and urine sample taken.
Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine will be analyzed for urinary iodine.
Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid disorders (multiplex multi-generation family involvement) will have their blood sent for whole exome sequencing and linkage analysis done to identify possible susceptible gene for autoimmune thyroid disorders
Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be referred to their nearest health centre for further evaluation and treatment appropriate for their condition.
- Conditions
- Hypothyroidism, Subclinical Hypothyroidism, Hyperthyroidism, Subclinical Hyperthyroidism, Graves Disease, Hashimoto's Thyroiditis
- Keywords
- Hyperthyroidism, Hypothyroidism, Autoimmune thyroid disorders, Iodine deficiency, Genetic susceptibility
- Medical subject headings
- Hypothyroidism, Hyperthyroidism, Graves Disease, Hashimoto Disease, Genetic Predisposition to Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal thyroid function
Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism
Measured: Day 0
Secondary outcomes (2)
Number of participants with positive thyroid autoantibodies
Anti-thyroglobulin Anti-thyroperoxidase
Measured: Day 0
Number of participants with Iodine deficiency status
Urinary iodine level
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionSep 2016
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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 2,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Islamic University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya, IMU University, Malaysia
- Responsible party
- Principal investigator, Dr Mohamnmad Arif Shahar, International Islamic University Malaysia
- Investigators
- Nor Azmi Kamaruddin, MBBS, MMed, Principal investigator, National University of MalaysiaNorlela Sukor, MMed, Phd, Principal investigator, National University of MalaysiaNorhanita Othman, Principal investigator, National University of MalaysiaJohari Ali, Principal investigator, University of MalayaShirenee Vethakkan, Principal investigator, University of MalayaSiew Kim Kwa, Principal investigator, IMU University, MalaysiaKuck Meng Chong, MD, Principal investigator, Malaysian Endocrine and Metabolic SocietyLecthuman Ramanathan, Principal investigator, Malaysian Endocrine and Metabolic Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190214
- Sponsor's protocol ID
- MyEndo-Thyroid
- Acronym
- MyEndo-Thyroid
- Status last verified
- Oct 2016
- First submitted
- 9 Jul 2014
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Disorders in Malaysian: A Nationwide Multicentre Study
- ClinicalTrials.gov ID
- NCT02190214
- Acronym / sponsor ID
- MyEndo-Thyroid / MyEndo-Thyroid
- Conditions
- Hypothyroidism, Subclinical Hypothyroidism, Hyperthyroidism, Subclinical Hyperthyroidism, Graves Disease, Hashimoto's Thyroiditis
- Keywords
- Hyperthyroidism, Hypothyroidism, Autoimmune thyroid disorders, Iodine deficiency, Genetic susceptibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,498 participants (actual)
- Lead sponsor
- International Islamic University MalaysiaUniversity, hospital or other
- Collaborators
- Malaysian Endocrine and Metabolic Society, National University of Malaysia, University of Malaya, IMU University, Malaysia
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
This will be a population based study looking at the prevalence of thyroid disorders in Malaysia (including hypo- and hyperthyroidism, subclinical hypo- or hyperthyroidism) and its association with different ethnicity and iodine status. The study will also look at genetic susceptibility for autoimmune thyroid disorders in the Malaysian population
General hypotheses:
The prevalence of thyroid disorders in Malaysia is 10% for hypothyroidism and 2% for hyperthyroidism Hypo- and hyperthyroidism is associated with iodine status in our population There are different susceptibility gene for autoimmune thyroid disorder in different ethnicity in our population
Detailed description
This will be a cross-sectional population based study involving Malaysian adults (aged 18 year old and above). Cluster sampling will be used to select respondents that will be representative of the Malaysian population. Selected respondent will be interviewed, anthropometric measurement taken, blood and urine sample taken.
Blood will be analyzed for thyroid function (thyroxine, triiodothyronine and thyroid stimulating hormone), autoantibodies (anti-thyroperoxidase and anti-thyroglobulin). Urine will be analyzed for urinary iodine.
Those diagnosed with autoimmune thyroid disorders with strong family history of thyroid disorders (multiplex multi-generation family involvement) will have their blood sent for whole exome sequencing and linkage analysis done to identify possible susceptible gene for autoimmune thyroid disorders
Respondents detected to have hypo- or hyper- and subclinical hypo- or hyperthyroidism will be referred to their nearest health centre for further evaluation and treatment appropriate for their condition.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the time of sampling
Key inclusion criteria (2 listed)
- Aged equal or more than 18 years old at the time of sampling
- Malaysian citizen
Key exclusion criteria (1 listed)
- Respondents who did not give consent
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
Number of participants with abnormal thyroid function
Time frame: Day 0
Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism
2 secondary outcomes
Number of participants with positive thyroid autoantibodies
Time frame: Day 0
Number of participants with Iodine deficiency status
Time frame: Day 0
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 18 Oct 2016.
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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.
Nor Azmi Kamaruddin, MBBS, MMed principal investigator
National University of Malaysia
Norlela Sukor, MMed, Phd principal investigator
National University of Malaysia
Norhanita Othman principal investigator
National University of Malaysia
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothyroidism and Subclinical Hypothyroidism, run by International Islamic University Malaysia.
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 2 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 18 Oct 2016. 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?
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?
Number of participants with abnormal thyroid function (time frame: Day 0). 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 18 Oct 2016.