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

Nutritional Requirements Clinical Trial

Official title:

Study on Physiologic Requirement and Dietary Recommended Nutrient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04419103
• Other study ID #: NSFC-81803223
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

Description:

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.

Meanwhile, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Nutritional Requirements

Intervention

Other:
• no intervention
Natural exposure of iodine.

Locations

Country	Name	City	State
China	Shandong Institute for Endemic Disease Control and Research	Dezhou	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University	Shandong Institute for Endemic Disease Control and Research

Country where clinical trial is conducted

China, 

References & Publications (21)

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. — View 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. Erratum In: J Nutr. 2012 Jun;142(6):1128. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Nutrients. 2019 Jun 05;11(6): — View 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. — View Citation

Lazarus JH. Thyroid function in pregnancy. Br Med Bull. 2011;97:137-48. doi: 10.1093/bmb/ldq039. Epub 2010 Dec 23. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Am J Clin Nutr. 2005 Jul;82(1):203. — View 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary iodine concentration	µg/L	2 weeks
Primary	free triiodothyronine	pmol/L	2 weeks
Primary	water iodine intake	µg/day	2 weeks
Primary	diet iodine intake	µg/day	2 weeks
Primary	salt iodine concentration	µg/L	2 weeks
Primary	free thyroxine	pmol/L	2 weeks
Primary	thyroid-stimulating hormone	mIU/L	2 weeks
Primary	thyroperoxidase antibody	IU/mL	2 weeks
Primary	thyroglobulin antibody	IU/mL	2 weeks
Primary	urinary iodine excretion	µg/day	2 weeks
Primary	fecal iodine excretion	µg/day	2 weeks