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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05920603
Other study ID # MU-CIRB 2022/178.3006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 5, 2022
Est. completion date August 4, 2023

Study information

Verified date October 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date August 4, 2023
Est. primary completion date May 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 49 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Sanaephong, Kongmongta, and Koh Sadueng Villages Kanchanaburi

Sponsors (3)

Lead Sponsor Collaborator
Mahidol University ETH Zurich, Iodine Global Network

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

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. Erratum In: J Nutr. 2012 Jun;142(6):1128. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary iodine concentration 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 -20ÂșC until analysis. At INMU, the iodine concentration in urine will be measured using the Pino modification of the Sandell-Kolthoff reaction. 1 day
Secondary Iodine content in salt 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. 1 day
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