Nutritional Requirements Clinical Trial
Official title:
Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
Due to the lack of direct evidence of optimal iodine intake of Chinese children, pregnant and lactating women and infants were found during the recent revision of Chinese dietary reference intakes (DRIs) of iodine in 2013 by the applicant Pro. Zhang, and no systematical research about compensatory mechanism of iodine nutrition in lactating women was found yet. Previous study funded by United Nations International Children's Emergency Fund (UNICEF) cooperated with the international experts on iodine and key project of national natural science foundation of China under the guidance of Pro. Zhang, had obtained the safe intake range of iodine from children and pregnant women, more than 10 joint papers were published, which laid the foundation of population study and international cooperation.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 40 Years |
Eligibility |
Inclusion Criteria: - Women in their third trimester:?Aged 18-40, who have lived in the area for 1 year;?Single pregnancy;?Those who have no special dietary habits; - Lactating woman:?Breastfeeding a child;?Normal thyroid function during pregnancy;?Term delivery (38-42 weeks of gestation); - Infants and young children:?0-6 months;?Breastfeeding;?Full term (38-42 weeks of gestation);?Normal birth weight (2500-4000g);?The thyroid-stimulating hormone (TSH) value of heel blood was normal;?Apgar score 8. Exclusion Criteria: - Women in their third trimester:?Smoking or drinking;?Iodized drugs or contrast agents have been used in the past year;?A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc; - Lactating woman:?A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc; - Infants and young children:?Have pathological jaundice, autoimmune disease, congenital heart disease and other diseases. |
Country | Name | City | State |
---|---|---|---|
China | Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention | Beijing | |
China | Shandong Institute of Endemic Disease Control and Prevention | Shandong | |
Switzerland | Swiss federal institute of Technology (ETH) | Zurich | |
United States | Boston University School of Medicine; Iodine Global Network (IGN) | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University |
United States, China, Switzerland,
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Bizhanova A, Kopp P. Minireview: The sodium-iodide symporter NIS and pendrin in iodide homeostasis of the thyroid. Endocrinology. 2009 Mar;150(3):1084-90. doi: 10.1210/en.2008-1437. Epub 2009 Feb 5. Review. — View Citation
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Chan SS, Hams G, Wiley V, Wilcken B, McElduff A. Postpartum maternal iodine status and the relationship to neonatal thyroid function. Thyroid. 2003 Sep;13(9):873-6. — 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
Chen W, Sang Z, Tan L, Zhang S, Dong F, Chu Z, Wei W, Zhao N, Zhang G, Yao Z, Shen J, Zhang W. Neonatal thyroid function born to mothers living with long-term excessive iodine intake from drinking water. Clin Endocrinol (Oxf). 2015 Sep;83(3):399-404. doi: 10.1111/cen.12625. Epub 2014 Nov 5. — View Citation
Chen W, Wu Y, Lin L, Tan L, Shen J, Pearce EN, Guo X, Wang W, Bian J, Jiang W, Zhang W. 24-Hour Urine Samples Are More Reproducible Than Spot Urine Samples for Evaluation of Iodine Status in School-Age Children. J Nutr. 2016 Jan;146(1):142-6. doi: 10.3945/jn.115.215806. Epub 2015 Nov 25. — View Citation
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. — View Citation
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. — View Citation
Chen Y, Chen W, Du C, Fan L, Wang W, Gao M, Zhang Y, Cui T, Hao Y, Pearce EN, Wang C, Zhang W. Iodine Nutrition and Thyroid Function in Pregnant Women Exposed to Different Iodine Sources. Biol Trace Elem Res. 2019 Jul;190(1):52-59. doi: 10.1007/s12011-018-1530-8. Epub 2018 Oct 2. — View Citation
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De la Vieja A, Santisteban P. Role of iodide metabolism in physiology and cancer. Endocr Relat Cancer. 2018 Apr;25(4):R225-R245. doi: 10.1530/ERC-17-0515. Epub 2018 Feb 1. Review. — View Citation
Dold S, Zimmermann MB, Aboussad A, Cherkaoui M, Jia Q, Jukic T, Kusic Z, Quirino A, Sang Z, San Luis TO, Vandea E, Andersson M. Breast Milk Iodine Concentration Is a More Accurate Biomarker of Iodine Status Than Urinary Iodine Concentration in Exclusively Breastfeeding Women. J Nutr. 2017 Apr;147(4):528-537. doi: 10.3945/jn.116.242560. Epub 2017 Feb 22. — View Citation
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. — View Citation
Dworkin HJ, Jacquez JA, Beierwaltes WH. Relationship of iodine ingestion to iodine excretion in pregnancy. J Clin Endocrinol Metab. 1966 Dec;26(12):1329-42. — View Citation
Farebrother J, Zimmermann MB, Assey V, Castro MC, Cherkaoui M, Fingerhut R, Jia Q, Jukic T, Makokha A, San Luis TO, Wegmüller 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. — View Citation
Henjum S, Barikmo I, Strand TA, Oshaug A, Torheim LE. Iodine-induced goitre and high prevalence of anaemia among Saharawi refugee women. Public Health Nutr. 2012 Aug;15(8):1512-8. doi: 10.1017/S1368980011002886. Epub 2011 Nov 7. — View Citation
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* Note: There are 48 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disposable random urine | µg/L | baseline | |
Primary | Venous blood | µg/L | baseline | |
Primary | Water iodine intake | µg/day | baseline | |
Primary | Salt iodine concentration | µg/day | baseline | |
Primary | Colostrum | µg/L | 1 week | |
Primary | Mother and child urine randomly at one time | µg/L | 1 week | |
Primary | Neonatal heel blood | µg/L | 1 week | |
Primary | Thyroglobulin(TG) | ug/L | 1 week | |
Primary | Thyroid-stimulating hormone | mIU/L | 1 week | |
Primary | Infant disposable random urine | µg/L | 4 weeks | |
Primary | Infant disposable random urine | µg/L | 24 weeks | |
Primary | Infant disposable random urine | µg/L | 12 weeks | |
Primary | 24 h urine | µg/L | 4 weeks | |
Primary | 24 h urine | µg/L | 12 weeks | |
Primary | 24 h urine | µg/L | 24 weeks | |
Primary | Urinary iodine excretion | µg/day | 4 weeks | |
Primary | Urinary iodine excretion | µg/day | 12 weeks | |
Primary | Urinary iodine excretion | µg/day | 24 weeks | |
Primary | Milk output | µg/day | 4 weeks | |
Primary | Milk output | µg/day | 12 weeks | |
Primary | Milk output | µg/day | 24 weeks | |
Primary | Milk iodine excretion | µg/day | 4 weeks | |
Primary | Milk iodine excretion | µg/day | 12 weeks | |
Primary | Milk iodine excretion | µg/day | 24 weeks | |
Primary | Average iodine intake | µg/day | 4 weeks | |
Primary | Average iodine intake | µg/day | 12 weeks | |
Primary | Average iodine intake | µg/day | 24 weeks | |
Primary | Thyroid volume | cm³ | 1 week | |
Primary | Thyroid volume | cm³ | 4 weeks | |
Primary | Thyroid volume | cm³ | 12 weeks | |
Primary | Thyroid volume | cm³ | 24 weeks | |
Primary | Thyroid nodule | cm³ | 1 week | |
Primary | Thyroid nodule | cm³ | 4 weeks | |
Primary | Thyroid nodule | cm³ | 12 weeks | |
Primary | Thyroid nodule | cm³ | 24 weeks | |
Primary | Dried blood spot(DBS) | µg/L | 3 days | |
Primary | Dried blood spot(DBS) | µg/L | 12 weeks | |
Primary | Diet iodine intake | µg/day | 1 week | |
Primary | Fecal iodine excretion | µg/day | 1 week |
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