Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-02-22 @ 1:00 PM
Study NCT ID:
NCT05920603
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iodine Status of the Indigenous Peoples (Karen) Living in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-20', 'studyFirstSubmitDate': '2023-06-17', 'studyFirstSubmitQcDate': '2023-06-17', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary iodine concentration', 'timeFrame': '1 day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Iodine content in salt', 'timeFrame': '1 day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iodine Deficiency']}, 'referencesModule': {'references': [{'pmid': '18676011', 'type': 'BACKGROUND', 'citation': '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': '22378324', 'type': 'BACKGROUND', 'citation': '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': '33989173', 'type': 'BACKGROUND', 'citation': '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': '8595717', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://apps.who.int/iris/bitstream/handle/10665/43781/9789241595827_eng.pdf?sequence=1&isAllowed=y', 'label': 'World Health Organization. Assessment of iodine deficiency disorders and monitoring their elimination. Geneva: World Health Organization, 2007.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nHowever, 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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '6 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'genderDescription': '* school-aged children (6-12 years) group recruited both male and female\n* women of reproductive age (15-49 years) group recruited only female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Karen ethnic population living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand\n* Healthy school-aged children, male and female, aged 6 -12 years old (n=300)\n* Healthy reproductive-aged women, aged 15 - 49 years old (n=300)\n* Can follow the steps of this study\n\nExclusion Criteria:\n\n* NO'}, 'identificationModule': {'nctId': 'NCT05920603', 'briefTitle': 'Iodine Status of the Indigenous Peoples (Karen) Living in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Iodine Status of the Indigenous Peoples (Karen) Living in Laiwo Subdistrict, Sangkhlaburi District, Kanchanaburi Province, Thailand', 'orgStudyIdInfo': {'id': 'MU-CIRB 2022/178.3006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'School-aged children (6-12 years old) and women of reproductive age (15-49 years old)', 'description': '300 healthy school-aged children (6-12 years old), and 300 healthy reproductive-aged women, aged (15-49 years old)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71240', 'city': 'Kanchanaburi', 'country': 'Thailand', 'facility': 'Sanaephong, Kongmongta, and Koh Sadueng Villages', 'geoPoint': {'lat': 14.00412, 'lon': 99.54832}}], 'overallOfficials': [{'name': 'Sueppong Gowachirapant, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iodine Global Network', 'class': 'UNKNOWN'}, {'name': 'ETH Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}