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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Thailand

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

  1. To investigate the nutritional status of school-aged children (SAC) living in Phu Kut City, Xieng Khouang province.
  2. 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)

  1. Iodize salt (spoon tradename) Koksaath 34.8
  2. Iodize salt (spoon tradename) Koksaath 23.8
  3. Iodize salt (spoon tradename) Koksaath 26.7
  4. Iodize salt (spoon tradename) Koksaath 1
  5. Iodize salt (carriage tradename) Vernkham 19.4
  6. Iodize salt (carriage tradename) Vernkham 22.5
  7. Iodize salt (carriage tradename) Vernkham 24.1
  8. Muối i ốt (Female tradename) Vietnam iodize salt 1
  9. Muối i ốt (Female tradename) Vietnam iodize salt 3.4
  10. 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

  1. To investigate the nutritional status of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
  2. To investigate the iodine status and iodized salt use of school-aged children (SAC) living in Phu Kut city, Xieng Khouang province.
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.

  1. 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)
  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.

  1. First posted17 May 2023
  2. Study start1 Apr 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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)
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 23746772
  • IFPRI. 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 25979494
  • Hilal 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 8595717
  • Country Nutrition Profiles: Lao PDR. Global Nutrition Report 2021. Available at: https://globalnutritionreport.org/resources/nutrition-profiles/asia/south-eastern-asia/lao-peoples-democratic-republic/.

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.

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