Iodine DeficiencyNCT05862376
Nutritional Status and Iodized Salt Use Among School-aged Children
An observational study of Iodine Deficiency, run by Mahidol University at 2 sites in Thailand.
Trial summary
To determine and explore the iodized salt concentration provided in the local community, especially in the Phu Kut district whether it meets the standard or not. This district is located in a mountainous area which means that the local community confronts with geographical access due to the limited transportation and… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 367 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Apr 2021to 30 Sep 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.
Who may be able to join
- School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.
Who cannot join
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Institute of Nutrition Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
Institute of Nutrition
Salaya, Changwat Nakhon Pathom, 73170
About this study
Official title: Nutritional Status and Iodized Salt Use Among School-aged Children Living in Phu Kut City, Xieng Khouang Province, Lao PDR
To determine and explore the iodized salt concentration provided in the local community, especially in the Phu Kut district whether it meets the standard or not. This district is located in a mountainous area which means that the local community confronts with geographical access due to the limited transportation and road condition, in addition, it is quite far from downtown approximately 26 kilometers and it is difficult to access the iodized salt consumption.
On the other hand, since 2013, the Lao People's Democratic Republic has implemented the iodized survey of urine among the primary students, this time could be the chance to compare based on the previous data, which will be an important source of the data for certifying the quality of iodized salt available in the local community that could be one cause of lacking iodized salt intake. Furthermore, the investigators could conduct the survey and monitor the current action plan related to iodized consumption in Laos as well, in order to eradicate diseases concerning with lacking iodized salt intake.
Read more
Objectives
- To investigate the nutritional status of school-aged children (SAC) living in Phu Kut City, Xieng Khouang province.
- To investigate the iodine status and iodized salt use of school-aged children (SAC) living in Phu Kut City, Xieng Khouang province.
Read the detailed description
Malnutrition Situation in Lao PDR. The Lao PDR has witnessed significant improvements in its Gross Domestic Product (GDP) for the past 2 decades. However, this does not commensurate with reductions in food insecurity and malnutrition (NNS, 2016). There exist significant disparities in income and living conditions between the rich and the poor; rural and urban dwellers; literates and illiterates (MOH-Lao PDR, 2014).
Lao PDR has the highest prevalence of stunting in the ASEAN region with an estimated 33% of children under 5 years being too short for their age (stunted) and 9.6% acutely malnourished (LSIS, 2017). Whilst recognizing the marginal reductions in the prevalence of malnutrition, the rates are relatively higher than recommended thresholds and of public health significance.
Micronutrient deficiency among the population is at an alarming level and calls for urgent action. 2 out of 5 children under 5 years are anemic and another 30% of preschool children are suffering from Vitamin A Deficiency (VAD). 36.2% of women in reproductive age are anemic with less than 20% of the general population consuming adequately iodized salt (LSIS, 2011-2012). In 2017, it can be seen that in the whole country, there are households that consume iodized salt increased to 89.2%, specifically in Xieng Khouang province it is 87.6% (LSIS, 2017).
Most recently in 2018, according to the monitoring report on the quality of iodized salt of the Department of Food and Drug, the Ministry of Health conducted a survey to check the quality of iodized salt in 8 provinces: Vientian capital (Vernkham salt factory), Vientiane province (Ban Bor salt factory), Lung Namtha province (Boten salt factory), Oudomxay province (Elephant brand salt factory), Borikhamxay (Song Kone Salt factory), Savannakhet (Natei Salt factory, Kasay Salt factory and Kasay Thip salt factory), Xieng Khouang province and Huaphan province (imported salt, market salt and household salt). This report found that only 2 out of 9 salt factories produced iodized salt according to the standard (40 ppm -60 ppm) namely Vern Kham Salt Factory and Salt Factory, almost 80% of factory machinery is dilapidated, lack of improvement, looking for spare parts for injectors, there is no place to sell them, lack of mixing techniques and iodine is expensive.
In the Xieng Khouang province, there is no any iodized salt factory, the local people just consumed the imported products. but they could detect the iodized salt concentration selling in the market and in the household. The results from iodized salt testing from 5 target districts have been done from the sampling in the district for a total of 125 samples from 10 trade names of the iodized salt. Unfortunately, there is no iodized salt trade name that meets the standard. Referring to the detail of the trade name and results of iodized salt testing below from five target districts:
No Iodized salt brand name Factory Iodine content (ppm)
- Iodize salt (spoon tradename) Koksaath 34.8
- Iodize salt (spoon tradename) Koksaath 23.8
- Iodize salt (spoon tradename) Koksaath 26.7
- Iodize salt (spoon tradename) Koksaath 1
- Iodize salt (carriage tradename) Vernkham 19.4
- Iodize salt (carriage tradename) Vernkham 22.5
- Iodize salt (carriage tradename) Vernkham 24.1
- Muối i ốt (Female tradename) Vietnam iodize salt 1
- Muối i ốt (Female tradename) Vietnam iodize salt 3.4
- Muối i ốt (Female tradename) Vietnam iodize salt 2.3
To determine and explore the iodized salt concentration provided in the local community, especially in the Phu Kut district whether it meets the standard or not. This district is located in a mountainous area which means that the local community confronts with geographical access due to the limited transportation and road condition, in addition, it is quite far from downtown approximately 26 kilometers and it is difficult to access the iodized salt consumption.
On the other hand, since 2013, the Lao People's Democratic Republic has implemented the iodized survey of urine among the primary students, this time could be the chance to compare based on the previous data, which will be an important source of the data for certifying the quality of iodized salt available in the local community that could be one cause of lacking iodized salt intake. Furthermore, the investigators could conduct the survey and monitor the current action plan related to iodized consumption in Laos as well, in order to eradicate diseases concerning with lacking of iodized salt intake.
Objectives
- To investigate the nutritional status of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
- To investigate the iodine status and iodized salt use of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
- Conditions
- Iodine Deficiency
- Keywords
- Nutritional status, Iodized salt, School-aged children
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine status
Median iodine urinary concentration of school-age children (cut-off values for urinary iodine; deficiency, iodine urinary concentration <100 ug/L, adequate, iodine urinary concentration 100 -199 ug/L, above requirement, iodine urinary concentration 200-299 ug/L, excessive, iodine urinary concentration ≥300).
Measured: 1 year
Secondary outcomes (1)
iodized salt use
Iodine content in salt samples was analyzed by iodometric titration in the analytical room.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start1 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khouanheuane Sengkhamyong, PhD., Principal investigator, Vientiane, Lao PDR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862376
- Sponsor's protocol ID
- 067/NECHR
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
PubMed 23746772IFPRI. Global Nutrition Report 2016: From Promise to Impact: Ending Malnutrition by 2030. International Food Policy Research Institute, 2016 Washington, DC.
McGuire S. International Food Policy Research Institute. 2014. Washington, DC: Global Nutrition Report 2014: actions and accountability to accelerate the world's progress on nutrition. Adv Nutr. 2015 May 15;6(3):278-9. doi: 10.3945/an.115.008599. Print 2015 May. No abstract available.
PubMed 25979494Hilal E. Nutrition, human rights, and the SDGs-21st Century Global Dynamics. Global-e 2016; Vol 9, Issue 11.
UNICEF. State of the world's children: A fair chance for every child, UNICEF, 2016 New York.
ASEAN/UNICEF/WHO. Regional Report on Nutrition Security in ASEAN, 2016 Volume 2. Bangkok; UNICEF.
Government of Lao PDR. National Nutrition Strategy and Plan of Action 2016-2020 (NNSPA, 2016-2020). 2015.
Ministry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2011 - 12 (Multiple Indicator Cluster Survey / Demographic and Health Survey), December 2012.
Ministry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2017 (Multiple Indicator Cluster Survey / Demographic and Health Survey). 2018.
National strategy on Nutrition 2025 and Plan of Action 2016-2020, Lao PDR.
WHO Growth reference data for 5-19 years, 2007. Available at: https://www.who.int/tools/growth-reference-data-for-5to19-years/indicators.
The International Council for Control of Iodine Deficiency Disorders (ICCIDD), 1995, Monitoring Universal Salt Iodization Programmes, January 1995, pp. 86-101.
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.
PubMed 8595717Country Nutrition Profiles: Lao PDR. Global Nutrition Report 2021. Available at: https://globalnutritionreport.org/resources/nutrition-profiles/asia/south-eastern-asia/lao-peoples-democratic-republic/.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status and Iodized Salt Use Among School-aged Children Living in Phu Kut City, Xieng Khouang Province, Lao PDR
- ClinicalTrials.gov ID
- NCT05862376
- Acronym / sponsor ID
- 067/NECHR
- Conditions
- Iodine Deficiency
- Keywords
- Nutritional status, Iodized salt, School-aged children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 May 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.
To determine and explore the iodized salt concentration provided in the local community, especially in the Phu Kut district whether it meets the standard or not. This district is located in a mountainous area which means that the local community confronts with geographical access due to the limited transportation and road condition, in addition, it is quite far from downtown approximately 26 kilometers and it is difficult to access the iodized salt consumption.
On the other hand, since 2013, the Lao People's Democratic Republic has implemented the iodized survey of urine among the primary students, this time could be the chance to compare based on the previous data, which will be an important source of the data for certifying the quality of iodized salt available in the local community that could be one cause of lacking iodized salt intake. Furthermore, the investigators could conduct the survey and monitor the current action plan related to iodized consumption in Laos as well, in order to eradicate diseases concerning with lacking iodized salt intake.
Objectives
- To investigate the nutritional status of school-aged children (SAC) living in Phu Kut City, Xieng Khouang province.
- To investigate the iodine status and iodized salt use of school-aged children (SAC) living in Phu Kut City, Xieng Khouang province.
Detailed description
Malnutrition Situation in Lao PDR. The Lao PDR has witnessed significant improvements in its Gross Domestic Product (GDP) for the past 2 decades. However, this does not commensurate with reductions in food insecurity and malnutrition (NNS, 2016). There exist significant disparities in income and living conditions between the rich and the poor; rural and urban dwellers; literates and illiterates (MOH-Lao PDR, 2014).
Lao PDR has the highest prevalence of stunting in the ASEAN region with an estimated 33% of children under 5 years being too short for their age (stunted) and 9.6% acutely malnourished (LSIS, 2017). Whilst recognizing the marginal reductions in the prevalence of malnutrition, the rates are relatively higher than recommended thresholds and of public health significance.
Micronutrient deficiency among the population is at an alarming level and calls for urgent action. 2 out of 5 children under 5 years are anemic and another 30% of preschool children are suffering from Vitamin A Deficiency (VAD). 36.2% of women in reproductive age are anemic with less than 20% of the general population consuming adequately iodized salt (LSIS, 2011-2012). In 2017, it can be seen that in the whole country, there are households that consume iodized salt increased to 89.2%, specifically in Xieng Khouang province it is 87.6% (LSIS, 2017).
Most recently in 2018, according to the monitoring report on the quality of iodized salt of the Department of Food and Drug, the Ministry of Health conducted a survey to check the quality of iodized salt in 8 provinces: Vientian capital (Vernkham salt factory), Vientiane province (Ban Bor salt factory), Lung Namtha province (Boten salt factory), Oudomxay province (Elephant brand salt factory), Borikhamxay (Song Kone Salt factory), Savannakhet (Natei Salt factory, Kasay Salt factory and Kasay Thip salt factory), Xieng Khouang province and Huaphan province (imported salt, market salt and household salt). This report found that only 2 out of 9 salt factories produced iodized salt according to the standard (40 ppm -60 ppm) namely Vern Kham Salt Factory and Salt Factory, almost 80% of factory machinery is dilapidated, lack of improvement, looking for spare parts for injectors, there is no place to sell them, lack of mixing techniques and iodine is expensive.
In the Xieng Khouang province, there is no any iodized salt factory, the local people just consumed the imported products. but they could detect the iodized salt concentration selling in the market and in the household. The results from iodized salt testing from 5 target districts have been done from the sampling in the district for a total of 125 samples from 10 trade names of the iodized salt. Unfortunately, there is no iodized salt trade name that meets the standard. Referring to the detail of the trade name and results of iodized salt testing below from five target districts:
No Iodized salt brand name Factory Iodine content (ppm)
- Iodize salt (spoon tradename) Koksaath 34.8
- Iodize salt (spoon tradename) Koksaath 23.8
- Iodize salt (spoon tradename) Koksaath 26.7
- Iodize salt (spoon tradename) Koksaath 1
- Iodize salt (carriage tradename) Vernkham 19.4
- Iodize salt (carriage tradename) Vernkham 22.5
- Iodize salt (carriage tradename) Vernkham 24.1
- Muối i ốt (Female tradename) Vietnam iodize salt 1
- Muối i ốt (Female tradename) Vietnam iodize salt 3.4
- Muối i ốt (Female tradename) Vietnam iodize salt 2.3
To determine and explore the iodized salt concentration provided in the local community, especially in the Phu Kut district whether it meets the standard or not. This district is located in a mountainous area which means that the local community confronts with geographical access due to the limited transportation and road condition, in addition, it is quite far from downtown approximately 26 kilometers and it is difficult to access the iodized salt consumption.
On the other hand, since 2013, the Lao People's Democratic Republic has implemented the iodized survey of urine among the primary students, this time could be the chance to compare based on the previous data, which will be an important source of the data for certifying the quality of iodized salt available in the local community that could be one cause of lacking iodized salt intake. Furthermore, the investigators could conduct the survey and monitor the current action plan related to iodized consumption in Laos as well, in order to eradicate diseases concerning with lacking of iodized salt intake.
Objectives
- To investigate the nutritional status of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
- To investigate the iodine status and iodized salt use of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.
Key inclusion criteria (1 listed)
- School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.
Key exclusion criteria (1 listed)
- Inability to understand the information sheet and the informed consent form due to cognitive or language reasons
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
Iodine status
Time frame: 1 year
Median iodine urinary concentration of school-age children (cut-off values for urinary iodine; deficiency, iodine urinary concentration <100 ug/L, adequate, iodine urinary concentration 100 -199 ug/L, above requirement, iodine urinary concentration 200-299 ug/L, excessive, iodine urinary concentration ≥300).
1 secondary outcome
iodized salt use
Time frame: 1 year
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 17 May 2023.
- Background: PubMed 23746772Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
- BackgroundIFPRI. Global Nutrition Report 2016: From Promise to Impact: Ending Malnutrition by 2030. International Food Policy Research Institute, 2016 Washington, DC.
- Background: PubMed 25979494McGuire S. International Food Policy Research Institute. 2014. Washington, DC: Global Nutrition Report 2014: actions and accountability to accelerate the world's progress on nutrition. Adv Nutr. 2015 May 15;6(3):278-9. doi: 10.3945/an.115.008599. Print 2015 May. No abstract available.
- BackgroundHilal E. Nutrition, human rights, and the SDGs-21st Century Global Dynamics. Global-e 2016; Vol 9, Issue 11.
- BackgroundUNICEF. State of the world's children: A fair chance for every child, UNICEF, 2016 New York.
- BackgroundASEAN/UNICEF/WHO. Regional Report on Nutrition Security in ASEAN, 2016 Volume 2. Bangkok; UNICEF.
- BackgroundGovernment of Lao PDR. National Nutrition Strategy and Plan of Action 2016-2020 (NNSPA, 2016-2020). 2015.
- BackgroundMinistry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2011 - 12 (Multiple Indicator Cluster Survey / Demographic and Health Survey), December 2012.
- BackgroundMinistry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2017 (Multiple Indicator Cluster Survey / Demographic and Health Survey). 2018.
- BackgroundNational strategy on Nutrition 2025 and Plan of Action 2016-2020, Lao PDR.
- BackgroundWHO Growth reference data for 5-19 years, 2007. Available at: https://www.who.int/tools/growth-reference-data-for-5to19-years/indicators.
- BackgroundThe International Council for Control of Iodine Deficiency Disorders (ICCIDD), 1995, Monitoring Universal Salt Iodization Programmes, January 1995, pp. 86-101.
Related trials for Iodine Deficiency
Not yet recruitingPhase 4
Effects of Maternal Multiple Micronutrient Supplementation During Lactation on Child Development in Ethiopia
Iodine Deficiency, Nutrition Poor
Recruiting
Folic Acid Salt Study (FISFA Zambia)
Folate Deficiency, Neural Tube Defects
Recruiting
The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
Iodine Deficiency
Recruiting
EUthyroid2: the Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
Iodine Deficiency
Active, not recruiting
The Bioavailability of Iodine in Plant-based Milk Alternatives
Iodine Deficiency
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.
Khouanheuane Sengkhamyong, PhD. principal investigator
Vientiane, Lao PDR
2 sites 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 2 sites 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 1 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 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Iodine status (time frame: 1 year). 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 NCT05862376, which also lists 14 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 17 May 2023.