NCT02190214

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

July 9, 2014

Last Update Submit

October 17, 2016

Conditions

HypothyroidismSubclinical HypothyroidismHyperthyroidismSubclinical HyperthyroidismGraves DiseaseHashimoto's ThyroiditisIodine DeficiencyGenetic Susceptibility

Keywords

HyperthyroidismHypothyroidismAutoimmune thyroid disordersIodine deficiencyGenetic susceptibility

Outcome Measures

Primary Outcomes (1)

  • Number of participants with abnormal thyroid function

    Overt or subclinical hypothyroidism Overt or subclinical hyperthyroidism

    Day 0

Secondary Outcomes (2)

  • Number of participants with positive thyroid autoantibodies

    Day 0

  • Number of participants with Iodine deficiency status

    Day 0

Other Outcomes (1)

  • Number of participants with genetic susceptibility to autoimmune thyroid disorders

    Day 0

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult (aged equal or more than 18 years old ) Malaysian citizen living in Malaysia at the time of sampling

You may qualify if:

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

You may not qualify if:

  • Respondents who did not give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood Serum

MeSH Terms

Conditions

HypothyroidismHyperthyroidismGraves DiseaseHashimoto DiseaseGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Thyroid DiseasesEndocrine System DiseasesExophthalmosOrbital DiseasesEye DiseasesGoiterAutoimmune DiseasesImmune System DiseasesThyroiditis, AutoimmuneThyroiditisDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nor Azmi Kamaruddin, MBBS, MMed

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

  • Norlela Sukor, MMed, Phd

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

  • Norhanita Othman

    National University of Malaysia

    PRINCIPAL INVESTIGATOR

  • Johari Ali

    University of Malaya

    PRINCIPAL INVESTIGATOR

  • Shirenee Vethakkan

    University of Malaya

    PRINCIPAL INVESTIGATOR

  • Siew Kim Kwa

    IMU University, Malaysia

    PRINCIPAL INVESTIGATOR

  • Kuck Meng Chong, MD

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Lecthuman Ramanathan

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Hussein Zanariah

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Nurain Mohd Noor

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Norhaliza Mohd Ali

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Norhayati Yahya

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

  • Nor Azizah Aziz

    Malaysian Endocrine and Metabolic Society

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 15, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

October 18, 2016

Record last verified: 2016-10