NCT05920603

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

August 5, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

June 17, 2023

Last Update Submit

October 20, 2023

Conditions

Iodine Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • Iodine content in salt

    1 day

Study Arms (1)

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)

Eligibility Criteria

Age6 Years - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details* school-aged children (6-12 years) group recruited both male and female * women of reproductive age (15-49 years) group recruited only female
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanaephong, Kongmongta, and Koh Sadueng Villages

Kanchanaburi, 71240, Thailand

Location

Related Publications (4)

  • 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.

    PMID: 18676011BACKGROUND

  • 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.

    PMID: 22378324BACKGROUND

  • 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.

    PMID: 33989173BACKGROUND

  • 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

Related Links

Study Officials

  • Sueppong Gowachirapant, Ph.D.

    Mahidol University

    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

June 17, 2023

First Posted

June 27, 2023

Study Start

August 5, 2022

Primary Completion

May 12, 2023

Study Completion

August 4, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)