Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

NCT04419103 | Completed

• 1 other identifier: NSFC-81803223
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

Conditions

Nutritional Requirements

Keywords

nutrient; public nutrition; nutrition related diseases; nutrition epidemiology

Outcome Measures

Primary Outcomes (11)

• urinary iodine concentration

  μg/L

  2 weeks

• free triiodothyronine

  pmol/L

  2 weeks

• water iodine intake

  μg/day

  2 weeks

• diet iodine intake

  μg/day

  2 weeks

• salt iodine concentration

  μg/L

  2 weeks

• free thyroxine

  pmol/L

  2 weeks

• thyroid-stimulating hormone

  mIU/L

  2 weeks

• thyroperoxidase antibody

  IU/mL

  2 weeks

• thyroglobulin antibody

  IU/mL

  2 weeks

• urinary iodine excretion

  μg/day

  2 weeks

• fecal iodine excretion

  μg/day

  2 weeks

Interventions

no intervention OTHER

Natural exposure of iodine.

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

7-11 years old Primary school students who in grades 2, 3, 4 and 5 are the research subjects.They were recruited in Shandong.

You may qualify if:

• Normal 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

You may not qualify if:

• Long-term low-protein long-term low-heat energy malnutrition

Sponsors & Collaborators

• Tianjin Medical University: lead
• Shandong Institute for Endemic Disease Control and Research: collaborator

Study Sites (1)

Shandong Institute for Endemic Disease Control and Research

Dezhou, Shandong, China

Location

Related Publications (23)

• 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: 24108132 BACKGROUND

• 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: 29462974 BACKGROUND

• 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: 29063209 BACKGROUND

• 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: 22892867 BACKGROUND

• 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: 29446011 BACKGROUND

• 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: 22378324 BACKGROUND

• 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: 29279360 BACKGROUND

• 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: 15817861 BACKGROUND

• 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: 27927635 BACKGROUND

• 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: 29166388 BACKGROUND

• 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: 19578096 BACKGROUND

• 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: 18952598 BACKGROUND

• 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: 5762324 BACKGROUND

• 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: 22205314 BACKGROUND

• 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: 23472655 BACKGROUND

• 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: 12362593 BACKGROUND

• 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: 17118996 BACKGROUND

• 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: 23633204 BACKGROUND

• 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: 29236073 BACKGROUND

• 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: 28229359 BACKGROUND

• Lazarus JH. Thyroid function in pregnancy. Br Med Bull. 2011;97:137-48. doi: 10.1093/bmb/ldq039. Epub 2010 Dec 23.

  PMID: 21186204 BACKGROUND

• 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: 37146180 DERIVED

• 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.

  PMID: 32687189 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

Study Officials

• xiao ming Wang

  Shandong Institute for Endemic Disease Control and Research

  PRINCIPAL INVESTIGATOR

• gui jun Tan

  The First Central Hospital of Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• man Zhang

  Shandong Institute for Endemic Disease Control and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)