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Iodine Status of the Indigenous Peoples (Karen) Living in Thailand

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05920603
Recruitment Status : Completed
First Posted : June 27, 2023
Last Update Posted : October 23, 2023
Sponsor:
Collaborators:
Iodine Global Network
ETH Zurich
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
In describing the iodine status involving health conditions of the minority groups, this observational study aims to learn about the iodine status of the Indigenous Peoples (Karen) in a subdistrict in western Thailand. The Participants will be collected their urine to determine urinary iodine concentrations At the same time, their household salt will be also collected to determine iodine content.

Condition or disease
Iodine Deficiency

Detailed Description:

Iodine deficiency (ID) is a global public health problem, and it is estimated that almost 240 million school-aged children (SAC) worldwide have an insufficient iodine intake. Currently, severe ID is uncommon, but mild-to-moderate ID is still widespread on a global level, especially in the Asia region. Iodine deficiency causes multiple adverse effects on growth and development in all age groups. Salt iodization is recommended as the most cost-effective way of delivering iodine to the target population to combat iodine deficiency. In addition, the cyclic monitoring of urinary iodine concentration (UIC) in vulnerable groups is recommended by the World Health Organization (WHO).

However, some minority communities such as indigenous peoples living in remote rural areas are not included in IDD surveillance programs. Indigenous peoples in many developing countries, including Thailand, are largely ignored in development efforts, as they are disadvantaged minority groups in those societies. These indigenous peoples may therefore be at risk of many adverse health and nutrition consequences, resulting in their quality of life. In order to promote nutrition and health, and to ensure adequate iodine intake among indigenous peoples in Thailand, it is essential to understand the urinary iodine concentration of the populations and the iodine content in their household salt. The results from this study could then be considered and potentially strengthen the Universal Salt Iodization (USI) program in Thailand, to reach indigenous peoples in border areas.

This study will conduct in Karen communities in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand. The participants will be divided into 2 groups, school-aged children, males and females (6-12 years), and women of reproductive age (15-49 years). The Participants will be collected their urine to determine urinary iodine concentrations At the same time, their household salt will be also collected to determine iodine content.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Iodine Status of the Indigenous Peoples (Karen) Living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
Actual Study Start Date : August 5, 2022
Actual Primary Completion Date : May 12, 2023
Actual Study Completion Date : August 4, 2023

Group/Cohort
School-aged children (6-12 years old) and women of reproductive age (15-49 years old)
300 healthy school-aged children (6-12 years old), and 300 healthy reproductive-aged women, aged (15-49 years old)



Primary Outcome Measures :
  1. Urinary iodine concentration [ Time Frame: 1 day ]
    A spot urine samples will be collected from each participant at school or their home or a nearby village health promoting hospital. The urine samples will be transported on ice to the Institute of Nutrition of Mahidol University (INMU), divided into aliquots, and stored at -20ºC until analysis. At INMU, the iodine concentration in urine will be measured using the Pino modification of the Sandell-Kolthoff reaction.


Secondary Outcome Measures :
  1. Iodine content in salt [ Time Frame: 1 day ]
    The participants will be requested to bring 2 tablespoons of the salt which is commonly consumed in their household, in a tightly sealed plastic bag given by study team. The salt samples will be transported to the Institute of Nutrition of Mahidol University (INMU), and stored under dry conditions until analysis. At INMU, the iodine content in salt will be measured using iodometric titration technique.



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Ages Eligible for Study:   6 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  
  • school-aged children (6-12 years) group recruited both male and female
  • women of reproductive age (15-49 years) group recruited only female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The participants are the Karen ethnic population living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand. It is located in the Thungyai Naresuan National Wildlife Sanctuary some 336 km northwest of Bangkok adjacent to the Myanmar border, and about 12 km east of Sangkhlaburi municipality. The participants are divided into 2 groups, including school-aged children, males and females (6-12 years old), and women of reproductive age (15-49 years old).
Criteria

Inclusion Criteria:

  • Karen ethnic population living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
  • Healthy school-aged children, male and female, aged 6 -12 years old (n=300)
  • Healthy reproductive-aged women, aged 15 - 49 years old (n=300)
  • Can follow the steps of this study

Exclusion Criteria:

  • NO

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920603


Locations
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Thailand
Sanaephong, Kongmongta, and Koh Sadueng Villages
Kanchanaburi, Thailand, 71240
Sponsors and Collaborators
Mahidol University
Iodine Global Network
ETH Zurich
Investigators
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Principal Investigator: Sueppong Gowachirapant, Ph.D. Mahidol University
Additional Information:
Publications:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT05920603    
Other Study ID Numbers: MU-CIRB 2022/178.3006
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No