NCT05862376

Brief 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 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

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
367

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
Last Updated

May 17, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 27, 2023

Last Update Submit

May 7, 2023

Conditions

Keywords

Nutritional statusIodized saltSchool-aged children

Outcome Measures

Primary Outcomes (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).

    1 year

Secondary Outcomes (1)

  • iodized salt use

    1 year

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.

You may qualify if:

  • School-aged children aged 6-12 year olds and their parents who living in Phu Kut city, Xieng Khouang province.

You may not qualify if:

  • Inability to understand the information sheet and the informed consent form due to cognitive or language reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Nutrition Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Institute of Nutrition

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (14)

  • 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.

    PMID: 23746772BACKGROUND
  • IFPRI. Global Nutrition Report 2016: From Promise to Impact: Ending Malnutrition by 2030. International Food Policy Research Institute, 2016 Washington, DC.

    BACKGROUND
  • 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.

    PMID: 25979494BACKGROUND
  • Hilal E. Nutrition, human rights, and the SDGs-21st Century Global Dynamics. Global-e 2016; Vol 9, Issue 11.

    BACKGROUND
  • UNICEF. State of the world's children: A fair chance for every child, UNICEF, 2016 New York.

    BACKGROUND
  • ASEAN/UNICEF/WHO. Regional Report on Nutrition Security in ASEAN, 2016 Volume 2. Bangkok; UNICEF.

    BACKGROUND
  • Government of Lao PDR. National Nutrition Strategy and Plan of Action 2016-2020 (NNSPA, 2016-2020). 2015.

    BACKGROUND
  • Ministry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2011 - 12 (Multiple Indicator Cluster Survey / Demographic and Health Survey), December 2012.

    BACKGROUND
  • Ministry of Health & Lao Statistical Bureau. Lao Social Indicator Survey (LSIS) 2017 (Multiple Indicator Cluster Survey / Demographic and Health Survey). 2018.

    BACKGROUND
  • National strategy on Nutrition 2025 and Plan of Action 2016-2020, Lao PDR.

    BACKGROUND
  • WHO Growth reference data for 5-19 years, 2007. Available at: https://www.who.int/tools/growth-reference-data-for-5to19-years/indicators.

    BACKGROUND
  • The International Council for Control of Iodine Deficiency Disorders (ICCIDD), 1995, Monitoring Universal Salt Iodization Programmes, January 1995, pp. 86-101.

    BACKGROUND
  • 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.

    PMID: 8595717BACKGROUND
  • 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/.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

Study Officials

  • Khouanheuane Sengkhamyong, PhD.

    Vientiane, Lao PDR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2023

First Posted

May 17, 2023

Study Start

April 1, 2021

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

May 17, 2023

Record last verified: 2023-05

Locations