Clinical trial NCT05920603: Iodine Status of the Indigenous Peoples (Karen) Living in Thailand
Official title: Iodine Status of the Indigenous Peoples (Karen) Living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iodine Deficiency
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Iodine Global Network
name: ETH Zurich
First posted: 2023-06-27
Enrollment: 600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Urinary iodine concentration
timeFrame: 1 day
Secondary outcomes:
measure: Iodine content in salt
timeFrame: 1 day
Other outcomes:
Locations:
city: Kanchanaburi
country: Thailand
facility: Sanaephong, Kongmongta, and Koh Sadueng Villages
Study officials:
affiliation: Mahidol University
name: Sueppong Gowachirapant, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zimmermann MB, Jooste PL, Pandav CS. Iodine-deficiency disorders. Lancet. 2008 Oct 4;372(9645):1251-62. doi: 10.1016/S0140-6736(08)61005-3.
citation: Andersson M, Karumbunathan V, Zimmermann MB. Global iodine status in 2011 and trends over the past decade. J Nutr. 2012 Apr;142(4):744-50. doi: 10.3945/jn.111.149393. Epub 2012 Feb 29.
citation: Zimmermann MB, Andersson M. GLOBAL ENDOCRINOLOGY: Global perspectives in endocrinology: coverage of iodized salt programs and iodine status in 2020. Eur J Endocrinol. 2021 Jun 10;185(1):R13-R21. doi: 10.1530/EJE-21-0171.
citation: Pino S, Fang SL, Braverman LE. Ammonium persulfate: a safe alternative oxidizing reagent for measuring urinary iodine. Clin Chem. 1996 Feb;42(2):239-43.