Iodine DeficiencyNCT05920603
Iodine Status of the Indigenous Peoples (Karen) Living in Thailand
An observational study of Iodine Deficiency, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 6 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 600 participants
- Where
- 1 siteThailand
- Study dates
- 5 Aug 2022to 4 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- NO
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Sanaephong, Kongmongta, and Koh Sadueng Villages
Kanchanaburi, 71240
About this study
Official title: Iodine Status of the Indigenous Peoples (Karen) Living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
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.
Read the 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.
- Conditions
- Iodine Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 -20ºC until analysis. At INMU, the iodine concentration in urine will be measured using the Pino modification of the Sandell-Kolthoff reaction.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start5 Aug 2022
- Primary completion12 May 2023
- Study completion4 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Iodine Global Network, ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Sueppong Gowachirapant, Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920603
- Sponsor's protocol ID
- MU-CIRB 2022/178.3006
- Status last verified
- Oct 2023
- First submitted
- 17 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18676011Andersson 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.
PubMed 22378324Zimmermann 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.
PubMed 33989173Pino S, Fang SL, Braverman LE. Ammonium persulfate: a safe alternative oxidizing reagent for measuring urinary iodine. Clin Chem. 1996 Feb;42(2):239-43.
PubMed 8595717
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine Status of the Indigenous Peoples (Karen) Living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand
- ClinicalTrials.gov ID
- NCT05920603
- Acronym / sponsor ID
- MU-CIRB 2022/178.3006
- Conditions
- Iodine Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Iodine Global Network, ETH Zurich
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 6 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- NO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Iodine content in salt
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 18676011Zimmermann MB, Jooste PL, Pandav CS. Iodine-deficiency disorders. Lancet. 2008 Oct 4;372(9645):1251-62. doi: 10.1016/S0140-6736(08)61005-3.
- Background: PubMed 22378324Andersson 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.
- Background: PubMed 33989173Zimmermann 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.
- Background: PubMed 8595717Pino S, Fang SL, Braverman LE. Ammonium persulfate: a safe alternative oxidizing reagent for measuring urinary iodine. Clin Chem. 1996 Feb;42(2):239-43.
- World Health Organization. Assessment of iodine deficiency disorders and monitoring their elimination. Geneva: World Health Organization, 2007.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sueppong Gowachirapant, Ph.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920603, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.