Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shandong Institute for Endemic Disease Control and Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Iodine as an essential trace element for human, both excessive and insufficient intake would be harmful for human health. As susceptible population, children will be more sensitive to adverse effects caused by inadequate intake of iodine since they are at the peak of growth and development. Meanwhile, there are few direct evidence to establish dietary intakes levels of iodine for 3-6 years old pre-school children.
This study plan to conduct iodine balance experiment by providing devised diet consist of different iodine contents, in order to simulate iodine equilibrium of iodine deficiency to iodine excess in children and find the lowest iodine requirement of iodine for pre-school children, then aim to provide data to establish recommend nutrient intake of iodine for 3-6-year-old pre-school children. On the other hand, this study will make use of natural geographic environment with high water iodine in China. The investigators will conduct big-scale epidemiologic study in areas with high water iodine levels in Shandong and areas with adequate iodine in Tianjin, to enroll pre-school children with various iodine intake levels. The investigators will collect 24-hour urine samples as well as dietary records to evaluate iodine intake levels, and detect thyroid volume and thyroglobulin to evaluate the effects of various iodine intake on pre-school children, aiming to find the lowest safe intake level of iodine and then establish the tolerable upper intake level (UL) of iodine for 3-6-year-old pre-school children. This study aims to define the RNI and UL of iodine for 3-6-year-old pre-school children, to provide data for revision of Chinese dietary intake levels of iodine, and to guide children safe and scientifical iodine fortification.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | Natural exposure of iodine |
| Measure | Description | Time Frame |
|---|---|---|
| urinary iodine concentration | μg/L | 2 weeks |
| diet iodine intake | μg/day | 2 weeks |
| urinary iodine excretion | μg/day | 2 weeks |
| thyroglobulin antibody | IU/mL | 2 weeks |
| salt iodine concentration | μg/L | 2 weeks |
| water iodine intake | μg/day | 2 weeks |
| thyroid volume | ml | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Not provided
Not provided
3-6 years old pre-school children are the research subjects. They were recruited in Tianjin and Shandong.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wen Chen, Master | Contact | 022-83336610 | wenchen@tmu.edu.cn | |
| ying ye | Contact | 022-83336717 | yeying@tmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| xiao ming Wang | Shandong Institute for Endemic Disease Control and Research | Study Chair |
| dong An | Tianjin Children's Hospital | Study Chair |
| fang Fang |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Institute for Endemic Disease Control and Research | Recruiting | Yuncheng | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20172467 | Background | Laurberg P, Cerqueira C, Ovesen L, Rasmussen LB, Perrild H, Andersen S, Pedersen IB, Carle A. Iodine intake as a determinant of thyroid disorders in populations. Best Pract Res Clin Endocrinol Metab. 2010 Feb;24(1):13-27. doi: 10.1016/j.beem.2009.08.013. | |
| 25591468 | Background | Zimmermann MB, Boelaert K. Iodine deficiency and thyroid disorders. Lancet Diabetes Endocrinol. 2015 Apr;3(4):286-95. doi: 10.1016/S2213-8587(14)70225-6. Epub 2015 Jan 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tianjin Medical University |
| Study Chair |
| na Sai | Tianjin Medical University | Study Chair |
| 32075540 | Background | Li Y, Teng D, Ba J, Chen B, Du J, He L, Lai X, Teng X, Shi X, Li Y, Chi H, Liao E, Liu C, Liu L, Qin G, Qin Y, Quan H, Shi B, Sun H, Tang X, Tong N, Wang G, Zhang JA, Wang Y, Xue Y, Yan L, Yang J, Yang L, Yao Y, Ye Z, Zhang Q, Zhang L, Zhu J, Zhu M, Ning G, Mu Y, Zhao J, Shan Z, Teng W. Efficacy and Safety of Long-Term Universal Salt Iodization on Thyroid Disorders: Epidemiological Evidence from 31 Provinces of Mainland China. Thyroid. 2020 Apr;30(4):568-579. doi: 10.1089/thy.2019.0067. Epub 2020 Mar 24. |
| 24108132 | Background | 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. |
| 25707780 | Background | Lee SY, Pearce EN. Reproductive endocrinology: Iodine intake in pregnancy--even a little excess is too much. Nat Rev Endocrinol. 2015 May;11(5):260-1. doi: 10.1038/nrendo.2015.28. Epub 2015 Feb 24. |
| 23609774 | Background | Bougma K, Aboud FE, Harding KB, Marquis GS. Iodine and mental development of children 5 years old and under: a systematic review and meta-analysis. Nutrients. 2013 Apr 22;5(4):1384-416. doi: 10.3390/nu5041384. |
| 27534632 | Background | Pearce EN, Lazarus JH, Moreno-Reyes R, Zimmermann MB. Consequences of iodine deficiency and excess in pregnant women: an overview of current knowns and unknowns. Am J Clin Nutr. 2016 Sep;104 Suppl 3(Suppl 3):918S-23S. doi: 10.3945/ajcn.115.110429. Epub 2016 Aug 17. |
| 17118996 | 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. |
| 23746772 | Background | Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6. |
| 28682645 | Background | Harika R, Faber M, Samuel F, Mulugeta A, Kimiywe J, Eilander A. Are Low Intakes and Deficiencies in Iron, Vitamin A, Zinc, and Iodine of Public Health Concern in Ethiopian, Kenyan, Nigerian, and South African Children and Adolescents? Food Nutr Bull. 2017 Sep;38(3):405-427. doi: 10.1177/0379572117715818. Epub 2017 Jul 6. |
| 23881585 | Background | Lee J, Kim JH, Lee SY, Lee JH. Iodine status in Korean preschool children as determined by urinary iodine excretion. Eur J Nutr. 2014;53(2):683-8. doi: 10.1007/s00394-013-0558-y. Epub 2013 Jul 24. |
| 24972786 | Background | Nakatsuka H, Watanabe T, Shimbo S, Sawatari H, Izumi K, Yaginuma-Sakurai K, Ikeda M. High iodine intake by preschool children in Miyagi prefecture, Japan. Environ Health Prev Med. 2014 Sep;19(5):330-8. doi: 10.1007/s12199-014-0394-6. Epub 2014 Jun 28. |
| 31727496 | Background | Wang Y, Cui Y, Chen C, Duan Y, Wu Y, Li W, Zhang D, Li F, Hou C. Stopping the supply of iodized salt alone is not enough to make iodine nutrition suitable for children in higher water iodine areas: A cross-sectional study in northern China. Ecotoxicol Environ Saf. 2020 Jan 30;188:109930. doi: 10.1016/j.ecoenv.2019.109930. Epub 2019 Nov 11. |
| 27927635 | 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. |
| 5762324 | 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. |
| 27465383 | Background | Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27. |
| 30526700 | Background | Tan L, Tian X, Wang W, Guo X, Sang Z, Li X, Zhang P, Sun Y, Tang C, Xu Z, Shen J, Zhang W. Exploration of the appropriate recommended nutrient intake of iodine in healthy Chinese women: an iodine balance experiment. Br J Nutr. 2019 Mar 14;121(5):519-528. doi: 10.1017/S0007114518003653. Epub 2018 Dec 11. |
| 32624007 | Background | Yang L, Wang J, Yang J, Zhang H, Liu X, Mao D, Lu J, Gu Y, Li X, Wang H, Xu J, Tan H, Zhang H, Yu W, Tao X, Fan Y, Cai Q, Liu X, Yang X. An iodine balance study to explore the recommended nutrient intake of iodine in Chinese young adults. Br J Nutr. 2020 Dec 14;124(11):1156-1165. doi: 10.1017/S0007114520002196. Epub 2020 Jun 22. |
| 12993583 | Background | RIGGS DS. Quantitative aspects of iodine metabolism in man. Pharmacol Rev. 1952 Sep;4(3):284-370. No abstract available. |
| 3340004 | Background | Paul T, Meyers B, Witorsch RJ, Pino S, Chipkin S, Ingbar SH, Braverman LE. The effect of small increases in dietary iodine on thyroid function in euthyroid subjects. Metabolism. 1988 Feb;37(2):121-4. doi: 10.1016/s0026-0495(98)90004-x. |
| 3139337 | Background | Gardner DF, Centor RM, Utiger RD. Effects of low dose oral iodide supplementation on thyroid function in normal men. Clin Endocrinol (Oxf). 1988 Mar;28(3):283-8. doi: 10.1111/j.1365-2265.1988.tb01214.x. |
| 22205314 | 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. |
| 29722836 | Background | Chen W, Zhang Y, Hao Y, Wang W, Tan L, Bian J, Pearce EN, Zimmermann MB, Shen J, Zhang W. Adverse effects on thyroid of Chinese children exposed to long-term iodine excess: optimal and safe Tolerable Upper Intake Levels of iodine for 7- to 14-y-old children. Am J Clin Nutr. 2018 May 1;107(5):780-788. doi: 10.1093/ajcn/nqy011. |
| 33941207 | Background | Xu T, Ren Z, Li S, Tan L, Zhang W. The relationship of different levels of high iodine and goiter in school children: a meta-analysis. Nutr Metab (Lond). 2021 May 3;18(1):46. doi: 10.1186/s12986-021-00563-2. |
| 28756810 | Background | DU Y, Gao YH, Feng ZY, Meng FG, Fan LJ, Sun DJ. Serum Thyroglobulin-A Sensitive Biomarker of Iodine Nutrition Status and Affected by Thyroid Abnormalities and Disease in Adult Populations. Biomed Environ Sci. 2017 Jul;30(7):508-516. doi: 10.3967/bes2017.067. |
| 28222819 | Background | Andersen S, Noahsen P, Westergaard L, Laurberg P. Reliability of thyroglobulin in serum compared with urinary iodine when assessing individual and population iodine nutrition status. Br J Nutr. 2017 Feb;117(3):441-449. doi: 10.1017/S0007114517000162. Epub 2017 Feb 22. |
| 30648484 | Background | Farebrother J, Zimmermann MB, Assey V, Castro MC, Cherkaoui M, Fingerhut R, Jia Q, Jukic T, Makokha A, San Luis TO, Wegmuller R, Andersson M. Thyroglobulin Is Markedly Elevated in 6- to 24-Month-Old Infants at Both Low and High Iodine Intakes and Suggests a Narrow Optimal Iodine Intake Range. Thyroid. 2019 Feb;29(2):268-277. doi: 10.1089/thy.2018.0321. |
| 26528830 | Background | Stinca S, Andersson M, Erhardt J, Zimmermann MB. Development and Validation of a New Low-Cost Enzyme-Linked Immunoassay for Serum and Dried Blood Spot Thyroglobulin. Thyroid. 2015 Dec;25(12):1297-305. doi: 10.1089/thy.2015.0428. Epub 2015 Dec 1. |
| 30696370 | Background | Chen W, Zhang Q, Wu Y, Wang W, Wang X, Pearce EN, Tan L, Shen J, Zhang W. Shift of Reference Values for Thyroid Volume by Ultrasound in 8- to 13-Year-Olds with Sufficient Iodine Intake in China. Thyroid. 2019 Mar;29(3):405-411. doi: 10.1089/thy.2018.0412. |