Thyroid Disorders in Malaysia: A Nationwide Multicentre Study

Completed

• Conditions: Hyperthyroidism; Genetic Susceptibility; Hypothyroidism; Hashimoto's Thyroiditis; Iodine Deficiency; Subclinical Hypothyroidism; Subclinical Hyperthyroidism; Graves Disease

• Registration Number: NCT02190214
• Lead Sponsor: International Islamic University Malaysia

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.

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2014-08
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2498

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal thyroid function	Day 0	Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism

Secondary Outcome Measures

Name	Time	Method
Number of participants with positive thyroid autoantibodies	Day 0	Anti-thyroglobulin Anti-thyroperoxidase
Number of participants with Iodine deficiency status	Day 0	Urinary iodine level