Clinical trial NCT02190214: Thyroid Disorders in Malaysia: A Nationwide Multicentre Study
Official title: Thyroid Disorders in Malaysian: A Nationwide Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothyroidism
Subclinical Hypothyroidism
Hyperthyroidism
Subclinical Hyperthyroidism
Graves Disease
Hashimoto's Thyroiditis
Iodine Deficiency
Genetic Susceptibility
Keywords: Hyperthyroidism
Hypothyroidism
Autoimmune thyroid disorders
Iodine deficiency
Genetic susceptibility
Lead sponsor: International Islamic University Malaysia
Sponsor class: OTHER
Collaborators: name: Malaysian Endocrine and Metabolic Society
name: National University of Malaysia
name: University of Malaya
name: International Medical University
First posted: 2014-07-15
Enrollment: 2498
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the time of sampling

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Aged equal or more than 18 years old at the time of sampling
* Malaysian citizen

Exclusion Criteria:

* Respondents who did not give consent

Primary outcomes:
measure: Number of participants with abnormal thyroid function
timeFrame: Day 0
Secondary outcomes:
measure: Number of participants with positive thyroid autoantibodies
timeFrame: Day 0
measure: Number of participants with Iodine deficiency status
timeFrame: Day 0
Other outcomes:
measure: Number of participants with genetic susceptibility to autoimmune thyroid disorders
timeFrame: Day 0
Locations:
Study officials:
affiliation: National University of Malaysia
name: Nor Azmi Kamaruddin, MBBS, MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Malaysia
name: Norlela Sukor, MMed, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Malaysia
name: Norhanita Othman
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Johari Ali
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Shirenee Vethakkan
role: PRINCIPAL_INVESTIGATOR
affiliation: International Medical University
name: Siew Kim Kwa
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Kuck Meng Chong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Lecthuman Ramanathan
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Hussein Zanariah
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Nurain Mohd Noor
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Norhaliza Mohd Ali
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Norhayati Yahya
role: PRINCIPAL_INVESTIGATOR
affiliation: Malaysian Endocrine and Metabolic Society
name: Nor Azizah Aziz
role: PRINCIPAL_INVESTIGATOR
References: