Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-29 @ 10:59 PM
Study NCT ID:
NCT04419103
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2020-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "1\\. Iodine nutrition survey of children was carried out in the villages and towns with low water iodine and no iodized salt supply. Basic information, venous blood, water samples, dietary information, spot urine and two 24-hour (24-h) urine were collected and thyroid ultrasound was performed to comprehensively assess children's thyroid function and iodine nutrition status. 2. An iodine balance experiment was conducted in children. All food and water ingested by the subjects were measured by the weighing method, and 24-h urine and feces were collected. Iodine intake and excretion were assessed, and saliva samples were collected six times a day."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary iodine concentration', 'timeFrame': '2 weeks', 'description': 'μg/L'}, {'measure': 'free triiodothyronine', 'timeFrame': '2 weeks', 'description': 'pmol/L'}, {'measure': 'water iodine intake', 'timeFrame': '2 weeks', 'description': 'μg/day'}, {'measure': 'diet iodine intake', 'timeFrame': '2 weeks', 'description': 'μg/day'}, {'measure': 'salt iodine concentration', 'timeFrame': '2 weeks', 'description': 'μg/L'}, {'measure': 'free thyroxine', 'timeFrame': '2 weeks', 'description': 'pmol/L'}, {'measure': 'thyroid-stimulating hormone', 'timeFrame': '2 weeks', 'description': 'mIU/L'}, {'measure': 'thyroperoxidase antibody', 'timeFrame': '2 weeks', 'description': 'IU/mL'}, {'measure': 'thyroglobulin antibody', 'timeFrame': '2 weeks', 'description': 'IU/mL'}, {'measure': 'urinary iodine excretion', 'timeFrame': '2 weeks', 'description': 'μg/day'}, {'measure': 'fecal iodine excretion', 'timeFrame': '2 weeks', 'description': 'μg/day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nutrient', 'public nutrition', 'nutrition related diseases', 'nutrition epidemiology'], 'conditions': ['Nutritional Requirements']}, 'referencesModule': {'references': [{'pmid': '24108132', 'type': 'BACKGROUND', 'citation': 'Sang Z, Chen W, Shen J, Tan L, Zhao N, Liu H, Wen S, Wei W, Zhang G, Zhang W. Long-term exposure to excessive iodine from water is associated with thyroid dysfunction in children. J Nutr. 2013 Dec;143(12):2038-43. doi: 10.3945/jn.113.179135. Epub 2013 Oct 9.'}, {'pmid': '29462974', 'type': 'BACKGROUND', 'citation': 'Brantsaeter AL, Knutsen HK, Johansen NC, Nyheim KA, Erlund I, Meltzer HM, Henjum S. Inadequate Iodine Intake in Population Groups Defined by Age, Life Stage and Vegetarian Dietary Practice in a Norwegian Convenience Sample. Nutrients. 2018 Feb 17;10(2):230. doi: 10.3390/nu10020230.'}, {'pmid': '29063209', 'type': 'BACKGROUND', 'citation': 'Pal N, Samanta SK, Chakraborty A, Chandra NK, Chandra AK. Interrelationship between iodine nutritional status of lactating mothers and their absolutely breast-fed infants in coastal districts of Gangetic West Bengal in India. Eur J Pediatr. 2018 Jan;177(1):39-45. doi: 10.1007/s00431-017-3025-6. Epub 2017 Oct 23.'}, {'pmid': '22892867', 'type': 'BACKGROUND', 'citation': 'Zimmermann MB, Andersson M. Update on iodine status worldwide. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):382-7. doi: 10.1097/MED.0b013e328357271a.'}, {'pmid': '29446011', 'type': 'BACKGROUND', 'citation': 'Delshad H, Mirmiran P, Abdollahi Z, Salehi F, Azizi F. Continuously sustained elimination of iodine deficiency: a quarter of a century success in the Islamic Republic of Iran. J Endocrinol Invest. 2018 Sep;41(9):1089-1095. doi: 10.1007/s40618-018-0838-8. Epub 2018 Feb 14.'}, {'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': '29279360', 'type': 'BACKGROUND', 'citation': 'Murcia M, Espada M, Julvez J, Llop S, Lopez-Espinosa MJ, Vioque J, Basterrechea M, Riano I, Gonzalez L, Alvarez-Pedrerol M, Tardon A, Ibarluzea J, Rebagliato M. Iodine intake from supplements and diet during pregnancy and child cognitive and motor development: the INMA Mother and Child Cohort Study. J Epidemiol Community Health. 2018 Mar;72(3):216-222. doi: 10.1136/jech-2017-209830. Epub 2017 Dec 26.'}, {'pmid': '15817861', 'type': 'BACKGROUND', 'citation': 'Zimmermann MB, Ito Y, Hess SY, Fujieda K, Molinari L. High thyroid volume in children with excess dietary iodine intakes. Am J Clin Nutr. 2005 Apr;81(4):840-4. doi: 10.1093/ajcn/81.4.840.'}, {'pmid': '27927635', 'type': 'BACKGROUND', 'citation': 'Chen W, Li X, Wu Y, Bian J, Shen J, Jiang W, Tan L, Wang X, Wang W, Pearce EN, Zimmermann MB, Carriquiry AL, Zhang W. Associations between iodine intake, thyroid volume, and goiter rate in school-aged Chinese children from areas with high iodine drinking water concentrations. Am J Clin Nutr. 2017 Jan;105(1):228-233. doi: 10.3945/ajcn.116.139725. Epub 2016 Dec 7.'}, {'pmid': '29166388', 'type': 'BACKGROUND', 'citation': 'Aakre I, Strand TA, Moubarek K, Barikmo I, Henjum S. Associations between thyroid dysfunction and developmental status in children with excessive iodine status. PLoS One. 2017 Nov 22;12(11):e0187241. doi: 10.1371/journal.pone.0187241. eCollection 2017.'}, {'pmid': '19578096', 'type': 'BACKGROUND', 'citation': 'Calza L, Fernandez M, Giardino L. Cellular approaches to central nervous system remyelination stimulation: thyroid hormone to promote myelin repair via endogenous stem and precursor cells. J Mol Endocrinol. 2010 Jan;44(1):13-23. doi: 10.1677/JME-09-0067. Epub 2009 Jul 3.'}, {'pmid': '18952598', 'type': 'BACKGROUND', 'citation': 'Liu HL, Lam LT, Zeng Q, Han SQ, Fu G, Hou CC. Effects of drinking water with high iodine concentration on the intelligence of children in Tianjin, China. J Public Health (Oxf). 2009 Mar;31(1):32-8. doi: 10.1093/pubmed/fdn097. Epub 2008 Oct 23.'}, {'pmid': '5762324', 'type': 'BACKGROUND', 'citation': 'Malvaux P, Beckers C, De Visscher M. Iodine balance studies in nongoitrous children and in adolescents on low iodine intake. J Clin Endocrinol Metab. 1969 Jan;29(1):79-84. doi: 10.1210/jcem-29-1-79. No abstract available.'}, {'pmid': '22205314', 'type': 'BACKGROUND', 'citation': 'Sang Z, Wang PP, Yao Z, Shen J, Halfyard B, Tan L, Zhao N, Wu Y, Gao S, Tan J, Liu J, Chen Z, Zhang W. Exploration of the safe upper level of iodine intake in euthyroid Chinese adults: a randomized double-blind trial. Am J Clin Nutr. 2012 Feb;95(2):367-73. doi: 10.3945/ajcn.111.028001. Epub 2011 Dec 28.'}, {'pmid': '23472655', 'type': 'BACKGROUND', 'citation': 'Pearce EN, Andersson M, Zimmermann MB. Global iodine nutrition: Where do we stand in 2013? Thyroid. 2013 May;23(5):523-8. doi: 10.1089/thy.2013.0128. Epub 2013 Apr 18.'}, {'pmid': '12362593', 'type': 'BACKGROUND', 'citation': 'Mason JB, Deitchler M, Gilman A, Gillenwater K, Shuaib M, Hotchkiss D, Mason K, Mock N, Sethuraman K. Iodine fortification is related to increased weight-for-age and birthweight in children in Asia. Food Nutr Bull. 2002 Sep;23(3):292-308. doi: 10.1177/156482650202300309.'}, {'pmid': '17118996', 'type': 'BACKGROUND', 'citation': 'Zimmermann MB, Jooste PL, Mabapa NS, Mbhenyane X, Schoeman S, Biebinger R, Chaouki N, Bozo M, Grimci L, Bridson J. Treatment of iodine deficiency in school-age children increases insulin-like growth factor (IGF)-I and IGF binding protein-3 concentrations and improves somatic growth. J Clin Endocrinol Metab. 2007 Feb;92(2):437-42. doi: 10.1210/jc.2006-1901. Epub 2006 Nov 21.'}, {'pmid': '23633204', 'type': 'BACKGROUND', 'citation': 'Hynes KL, Otahal P, Hay I, Burgess JR. Mild iodine deficiency during pregnancy is associated with reduced educational outcomes in the offspring: 9-year follow-up of the gestational iodine cohort. J Clin Endocrinol Metab. 2013 May;98(5):1954-62. doi: 10.1210/jc.2012-4249. Epub 2013 Apr 30.'}, {'pmid': '29236073', 'type': 'BACKGROUND', 'citation': 'Hynes KL, Otahal P, Burgess JR, Oddy WH, Hay I. Reduced Educational Outcomes Persist into Adolescence Following Mild Iodine Deficiency in Utero, Despite Adequacy in Childhood: 15-Year Follow-Up of the Gestational Iodine Cohort Investigating Auditory Processing Speed and Working Memory. Nutrients. 2017 Dec 13;9(12):1354. doi: 10.3390/nu9121354.'}, {'pmid': '28229359', 'type': 'BACKGROUND', 'citation': 'Vannucchi G, Covelli D, Vigo B, Perrino M, Mondina L, Fugazzola L. Thyroid volume and serum calcitonin changes during pregnancy. J Endocrinol Invest. 2017 Jul;40(7):727-732. doi: 10.1007/s40618-017-0622-1. Epub 2017 Feb 22.'}, {'pmid': '21186204', 'type': 'BACKGROUND', 'citation': 'Lazarus JH. Thyroid function in pregnancy. Br Med Bull. 2011;97:137-48. doi: 10.1093/bmb/ldq039. Epub 2010 Dec 23.'}, {'pmid': '37146180', 'type': 'DERIVED', 'citation': 'Guo W, Yang Y, Jiang W, Cheng Y, Wu W, Pan Z, Zhang D, Li S, Ren Z, Zhang N, Zhang K, Pearce EN, Chen W, Zhang W. An Iodine Balance Study in Chinese School-age Children. J Clin Endocrinol Metab. 2023 Sep 18;108(10):e949-e955. doi: 10.1210/clinem/dgad244.'}, {'pmid': '32687189', 'type': 'DERIVED', 'citation': 'Guo W, Pan Z, Zhang Y, Jin Y, Dong S, Wu W, Chen W, Zhang W. Saliva Iodine Concentration in Children and Its Association with Iodine Status and Thyroid Function. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa471. doi: 10.1210/clinem/dgaa471.'}]}, 'descriptionModule': {'briefSummary': 'Iodine is one of essential micronutrient for human, both iodine deficiency and excess will be harmful for human health. Children is the susceptible population to iodine nutrition, and studies show that even mild iodine deficiency would affect the growth and development of children, so it is urgent to identify the dietary recommended nutrient intake (RNI) of iodine for children to guide children scientifically and safely supplement iodine. There are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.', 'detailedDescription': 'Based on the investigators\'previous study on upper safe level of iodine on children from areas with high iodine in drinking water, this study will conduct an epidemiological study on 600 children living in areas with high water iodine content but the actual iodine content in participants\' drinking water is not so high, while no supply of iodized salt.\n\nMeanwhile, in order to get iodine dietary recommended nutrient intake (RNI) values of children. The investigators will conduct a iodine balance experiment on children with sufficient iodine nutrition. We will randomly select thirty healthy students for a three-day iodine balance experiment from the cross-sectional study. The investigators will use the regression model to obtain an iodine intake value when children at"zero iodine"balance. Combine the study at population and individual level, the investigators will obtain data on dietary recommended nutrient intake (RNI) of iodine for Chinese children, to properly guide children iodine supplementation to avoid iodine deficiency, which also will provide data for the update of Chinese dietary reference intakes of iodine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '7-11 years old Primary school students who in grades 2, 3, 4 and 5 are the research subjects.They were recruited in Shandong.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNormal body mass index and thyroid function have not been treated for thyroid disease have not used amiodarone and other drugs (including iodine supplements) during the investigation have no major diseases and family history have lived in the local area for more than 5 years\n\nExclusion Criteria:\n\nLong-term low-protein long-term low-heat energy malnutrition'}, 'identificationModule': {'nctId': 'NCT04419103', 'briefTitle': 'Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University'}, 'officialTitle': 'Study on Physiologic Requirement and Dietary Recommended Nutrient', 'orgStudyIdInfo': {'id': 'NSFC-81803223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'Natural exposure of iodine.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dezhou', 'state': 'Shandong', 'country': 'China', 'facility': 'Shandong Institute for Endemic Disease Control and Research', 'geoPoint': {'lat': 37.44661, 'lon': 116.36706}}], 'overallOfficials': [{'name': 'xiao ming Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Institute for Endemic Disease Control and Research'}, {'name': 'gui jun Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Central Hospital of Tianjin Medical University'}, {'name': 'man Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Institute for Endemic Disease Control and Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shandong Institute for Endemic Disease Control and Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teacher', 'investigatorFullName': 'Chen Wen', 'investigatorAffiliation': 'Tianjin Medical University'}}}}