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.

Study Overview

• Status: Recruiting
• Conditions: Nutritional Requirements
• Intervention / Treatment: Other: no intervention

Detailed Description

Studies indicate lactating women and their infants are the most vulnerable population to the adverse effects of iodine deficiency and excess, and because of the complexity of the study of lactating mothers and infants and the difficulty of sample collection, it is proposed to overcome this problem with the help of the advanced dried blood spot technique and iodine balance study method from the panel of Iodine Global Network (IGN). Investigators intend to recruit 900 late pregnant women in Tianjin, Hebei and Shandong;then establishing a dynamic cohort of breastfeeding mother-infant to 6 months after delivery to investigate the physiological compensatory mechanism of iodine nutrition in lactating women with the combination of animal experiment; On the other hand, 180 exclusively breastfeeding mother and infants within postpartum 0-6 months, will be selected to participate the iodine balance study.

Optimized method of iodine balance experiment of infants by both foreign partner and Pro. Zhang's team will be adopted to obtain the first iodine balance value of Chinese lactating women and infants,providing the direct evidence for the revision of DRIs in lactating women and infants, and guide the lactating women proper iodine supplementation to meet the requirements of both mothers and infants.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: ying ye; Phone Number: 022-83336717; Email: yeying@tmu.edu.cn
• Study Contact Backup: Name: WanQi Zhang, doctorate; Phone Number: 022-83336595; Email: wqzhang@tmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
    • Contact: ying ye; Phone Number: 022-83336717; Email: yeying@tmu.edu.cn
    • Contact: WanQi Zhang; Phone Number: 022-83336595; Email: wqzhang@tmu.edu.cn
  • Shandong, China
    • Recruiting
    • Shandong Institute of Endemic Disease Control and Prevention
    • Contact: Zhang WanQi; Phone Number: 022-83336595; Email: wqzhang@tmu.edu.cn
    • Contact: Ye ying; Phone Number: 022-83336717; Email: yeying@tmu.edu.cn
• Switzerland
  • Zurich, Switzerland
    • Recruiting
    • Swiss federal institute of Technology (ETH)
    • Contact: Michael B Zimmermann; Phone Number: +41-44-632-8657; Email: michael.zimmermann@hest.ethz.ch
    • Sub-Investigator: Maria Andersson
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02101-02117
      • Recruiting
      • Boston University School of Medicine; Iodine Global Network (IGN)
      • Contact: Elizabeth N Pearce; Phone Number: 617-414-1348; Email: elizabeth.pearce@bmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Women in the third trimester (18-40 years old), lactating women (38-42 weeks of gestation) and infants (0-6 months), all from Tianjin, Hebei and Shandong

Description

Inclusion Criteria:

• Women in their third trimester:⑴Aged 18-40, who have lived in the area for 1 year;⑵Single pregnancy;⑶Those who have no special dietary habits;
• Lactating woman:⑴Breastfeeding a child;⑵Normal thyroid function during pregnancy;⑶Term delivery (38-42 weeks of gestation);
• Infants and young children:⑴0-6 months;⑵Breastfeeding;⑶Full term (38-42 weeks of gestation);⑷Normal birth weight (2500-4000g);⑸The thyroid-stimulating hormone (TSH) value of heel blood was normal;⑹Apgar score 8.

Exclusion Criteria:

• Women in their third trimester:⑴Smoking or drinking;⑵Iodized drugs or contrast agents have been used in the past year;⑶A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
• Lactating woman:⑴A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
• Infants and young children:⑴Have pathological jaundice, autoimmune disease, congenital heart disease and other diseases.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disposable random urine	μg/L	baseline
Venous blood	μg/L	baseline
Water iodine intake	μg/day	baseline
Salt iodine concentration	μg/day	baseline
Colostrum	μg/L	1 week
Mother and child urine randomly at one time	μg/L	1 week
Neonatal heel blood	μg/L	1 week
Thyroglobulin(TG)	ug/L	1 week
Thyroid-stimulating hormone	mIU/L	1 week
Infant disposable random urine	μg/L	4 weeks
Infant disposable random urine	μg/L	24 weeks
Infant disposable random urine	μg/L	12 weeks
24 h urine	μg/L	4 weeks
24 h urine	μg/L	12 weeks
24 h urine	μg/L	24 weeks
Urinary iodine excretion	μg/day	4 weeks
Urinary iodine excretion	μg/day	12 weeks
Urinary iodine excretion	μg/day	24 weeks
Milk output	μg/day	4 weeks
Milk output	μg/day	12 weeks
Milk output	μg/day	24 weeks
Milk iodine excretion	μg/day	4 weeks
Milk iodine excretion	μg/day	12 weeks
Milk iodine excretion	μg/day	24 weeks
Average iodine intake	μg/day	4 weeks
Average iodine intake	μg/day	12 weeks
Average iodine intake	μg/day	24 weeks
Thyroid volume	cm³	1 week
Thyroid volume	cm³	4 weeks
Thyroid volume	cm³	12 weeks
Thyroid volume	cm³	24 weeks
Thyroid nodule	cm³	1 week
Thyroid nodule	cm³	4 weeks
Thyroid nodule	cm³	12 weeks
Thyroid nodule	cm³	24 weeks
Dried blood spot(DBS)	μg/L	3 days
Dried blood spot(DBS)	μg/L	12 weeks
Diet iodine intake	μg/day	1 week
Fecal iodine excretion	μg/day	1 week

Collaborators and Investigators

• Sponsor: Tianjin Medical University
• Investigators: Principal Investigator: ZiYun Pan, Tianjin Medical University; Principal Investigator: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention; Principal Investigator: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention; Principal Investigator: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention; Principal Investigator: GuiJun Tan, Tianjin Medical University; Principal Investigator: Wen Chen, Tianjin Medical University; Principal Investigator: YanTing Chen, Tianjin Medical University; Principal Investigator: Min Gao, Tianjin Medical University; Study Chair: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH); Study Chair: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN); Study Chair: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)

Publications and helpful links

General Publications

• Institute of Medicine (US) Panel on Micronutrients. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222310/
• Stinca S, Andersson M, Herter-Aeberli I, Chabaa L, Cherkaoui M, El Ansari N, Aboussad A, Weibel S, Zimmermann MB. Moderate-to-Severe Iodine Deficiency in the "First 1000 Days" Causes More Thyroid Hypofunction in Infants Than in Pregnant or Lactating Women. J Nutr. 2017 Apr;147(4):589-595. doi: 10.3945/jn.116.244665. Epub 2017 Feb 15.
• 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.
• 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.
• 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.
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• 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.
• 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.
• 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.
• 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. doi: 10.1210/jcem-26-12-1329. No abstract available.
• 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.
• Brough L, Thomson BM, Skeaff SA. Revisiting the Iodine Global Network's definition of iodine status by country. Br J Nutr. 2016 Jan 28;115(2):374-6. doi: 10.1017/S0007114515004389. Epub 2015 Dec 2. No abstract available.
• 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.
• 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.
• Pan Z, Cui T, Chen W, Gao S, Pearce EN, Wang W, Chen Y, Guo W, Tan L, Shen J, Zhang W. Serum iodine concentration in pregnant women and its association with urinary iodine concentration and thyroid function. Clin Endocrinol (Oxf). 2019 May;90(5):711-718. doi: 10.1111/cen.13945. Epub 2019 Mar 7.
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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.
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• Kleinau G, Biebermann H. Constitutive activities in the thyrotropin receptor: regulation and significance. Adv Pharmacol. 2014;70:81-119. doi: 10.1016/B978-0-12-417197-8.00003-1.
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• Thomasz L, Oglio R, Salvarredi L, Perona M, Rossich L, Copelli S, Pisarev M, Juvenal G. Regulation of NADPH oxidase NOX4 by delta iodolactone (IL-delta) in thyroid cancer cells. Mol Cell Endocrinol. 2018 Jul 15;470:115-126. doi: 10.1016/j.mce.2017.10.004. Epub 2017 Oct 7.
• Calil-Silveira J, Serrano-Nascimento C, Kopp PA, Nunes MT. Iodide excess regulates its own efflux: a possible involvement of pendrin. Am J Physiol Cell Physiol. 2016 Apr 1;310(7):C576-82. doi: 10.1152/ajpcell.00210.2015. Epub 2016 Jan 20.
• Perron B, Rodriguez AM, Leblanc G, Pourcher T. Cloning of the mouse sodium iodide symporter and its expression in the mammary gland and other tissues. J Endocrinol. 2001 Jul;170(1):185-96. doi: 10.1677/joe.0.1700185.
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• Nicola JP, Reyna-Neyra A, Carrasco N, Masini-Repiso AM. Dietary iodide controls its own absorption through post-transcriptional regulation of the intestinal Na+/I- symporter. J Physiol. 2012 Dec 1;590(23):6013-26. doi: 10.1113/jphysiol.2012.241307. Epub 2012 Sep 24.
• 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.
• Yu X, Shen H, Liu L, Lin L, Gao M, Wang S. Changes of sodium iodide symporter regulated by IGF-I and TGF-beta1 in mammary gland cells from lactating mice at different iodine levels. Biol Trace Elem Res. 2012 Apr;146(1):73-8. doi: 10.1007/s12011-011-9227-2. Epub 2011 Oct 13.
• Huynh D, Condo D, Gibson R, Muhlhausler B, Ryan P, Skeaff S, Makrides M, Zhou SJ. Iodine status of postpartum women and their infants in Australia after the introduction of mandatory iodine fortification. Br J Nutr. 2017 Jun;117(12):1656-1662. doi: 10.1017/S0007114517001775.
• Chung HR, Shin CH, Yang SW, Choi CW, Kim BI. Subclinical hypothyroidism in Korean preterm infants associated with high levels of iodine in breast milk. J Clin Endocrinol Metab. 2009 Nov;94(11):4444-7. doi: 10.1210/jc.2009-0632. Epub 2009 Oct 6.
• Liu L, Wang D, Liu P, Meng F, Wen D, Jia Q, Liu J, Zhang X, Jiang P, Shen H. The relationship between iodine nutrition and thyroid disease in lactating women with different iodine intakes. Br J Nutr. 2015 Nov 14;114(9):1487-95. doi: 10.1017/S0007114515003128. Epub 2015 Sep 14.
• Aakre I, Bjoro T, Norheim I, Strand TA, Barikmo I, Henjum S. Excessive iodine intake and thyroid dysfunction among lactating Saharawi women. J Trace Elem Med Biol. 2015;31:279-84. doi: 10.1016/j.jtemb.2014.09.009. Epub 2014 Oct 6.
• Nazeri P, Zarghani NH, Mirmiran P, Hedayati M, Mehrabi Y, Azizi F. Iodine Status in Pregnant Women, Lactating Mothers, and Newborns in an Area with More Than Two Decades of Successful Iodine Nutrition. Biol Trace Elem Res. 2016 Jul;172(1):79-85. doi: 10.1007/s12011-015-0575-1. Epub 2015 Dec 2.
• Nazeri P, Dalili H, Mehrabi Y, Hedayati M, Mirmiran P, Azizi F. Breast Milk Iodine Concentration Rather than Maternal Urinary Iodine Is a Reliable Indicator for Monitoring Iodine Status of Breastfed Neonates. Biol Trace Elem Res. 2018 Sep;185(1):71-77. doi: 10.1007/s12011-018-1246-9. Epub 2018 Jan 25.
• Henjum S, Kjellevold M, Ulak M, Chandyo RK, Shrestha PS, Froyland L, Strydom EE, Dhansay MA, Strand TA. Iodine Concentration in Breastmilk and Urine among Lactating Women of Bhaktapur, Nepal. Nutrients. 2016 Apr 28;8(5):255. doi: 10.3390/nu8050255.
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• Zimmermann MB, de Benoist B, Corigliano S, Jooste PL, Molinari L, Moosa K, Pretell EA, Al-Dallal ZS, Wei Y, Zu-Pei C, Torresani T. Assessment of iodine status using dried blood spot thyroglobulin: development of reference material and establishment of an international reference range in iodine-sufficient children. J Clin Endocrinol Metab. 2006 Dec;91(12):4881-7. doi: 10.1210/jc.2006-1370. Epub 2006 Sep 12.
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• Zimmermann MB, Aeberli I, Andersson M, Assey V, Yorg JA, Jooste P, Jukic T, Kartono D, Kusic Z, Pretell E, San Luis TO Jr, Untoro J, Timmer A. Thyroglobulin is a sensitive measure of both deficient and excess iodine intakes in children and indicates no adverse effects on thyroid function in the UIC range of 100-299 mug/L: a UNICEF/ICCIDD study group report. J Clin Endocrinol Metab. 2013 Mar;98(3):1271-80. doi: 10.1210/jc.2012-3952. Epub 2013 Jan 23.
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Helpful Links

• UNICEF. Global map of iodized salt coverage, http://www.ign.org/cm_data/UNICEF_map.jpg [M]. State of the World's Children, 2017. UNICEF. 2017.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: nutrition of special population; public nutrition; lactating women and infants; physiological compensatory mechanism; iodine balance study
• Other Study ID Numbers: NSFC-8191001159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No