Displacement of Iodine Balance Value During Pregnancy and the Mechanism of Breast Iodine Homeostasis During Lactation
NCT ID: NCT05730803
Last Updated: 2023-02-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
1200 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-02-17
Study Completion Date
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
In order to solve the bottleneck problems of"zero balance displacement"and"large variation of breastmilk"in the study of iodine EAR of pregnant women, lactating women and infants, firstly, this study intends to clarify the rate of metabolism and distribution of iodine during pregnancy by 125I tracer, SPECT/CT in vivo small animal imaging and γ counting study. Then, the iodine balance study in rats was conducted to verify the degree of "zero balance value displacement"caused by the difference of iodine absorption and store in different organs and tissues under different iodine exposure levels, so as to determine the iodine selection conditions of subjects in the population experiment. To determine the EAR of pregnant women by optimizing the population iodine balance experiment. Secondly, we proposed to study the regulatory mechanism of NIS and Pendrin in the mammary gland of lactating rats under different iodine nutrition levels to clarify the range of breastmilk iodine compensation. Mammary cell experiments intend to clarify the mutual regulations of iodine nutrition, oestrogen, and NIS and Pendrin. Based on the results of animal and cellular experiments, and the effect of genetic, oestrogen and iodine status were considered, a cross-sectional study of lactating women was conducted to determine the normal reference range of breastmilk iodine after screening out the people with abnormal indicators. This study will solve the bottleneck problems and difficulties in the iodine RNI research for pregnant women, lactating women and infants, found the iodine nutritional compensatory mechanism under special physiology, and provide the scientific basis for obtaining the accurate EAR basic data and the revision of iodine DRIs.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
NCT04492657
Nutritional Requirements
UNKNOWN
Assessment of the Daily Average Requirement of Iodine in Lactating Women
NCT05382793
Healthy
Iodine Deficiency
COMPLETED
NA
Effects of Breast Intervention During the Late Pregnancy on the Parturients' Breast Engorgement,Maternal Competence,and Stress
NCT05796284
Breastfeeding
Pregnancy Related
Efficacy, Self
RECRUITING
NA
Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai
NCT02070562
Breast Milk
UNKNOWN
A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
NCT05235412
Breast Feeding
Breast Milk Expression
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, the absorption, distribution, storage and excretion of 125I in rats were observed by small animal imaging technology in vivo, so as to clarify the characteristics of iodine metabolism under different iodine exposure, and provide a basis for optimizing the experimental cycle of iodine balance experiment. The iodine balance experiment of rats during pregnancy was carried out, the iodine storage in different organs was detected to explain the phenomenon of "zero point balance value shift", and the population with iodine nutrition background was determined as the experimental objects in the iodine balance experiment. The optimized iodine balance experiment was further verified in the population, and the iodine EAR of pregnant women was explored to provide reference data for formulating the recommended iodine intake of pregnant women in China in the future. The expression difference of NIS and Pendrin in lactating rats with different iodine nutritional status was used to determine the range of milk iodine compensation. To determine the synergistic and independent effects of iodine level and estrogen on the expression of NIS and Pendrin in lactating mammary gland cells cultured in primary culture. Through a cross-section study of lactating women, the correlation between milk iodine level and NIS, Pendrin gene mutation, iodine exposure level and estrogen was discussed, the phenomenon of "huge milk iodine variation" was explained, the normal reference range of milk iodine was defined, and the basis was laid for further determination of iodine AI and EAR of lactating mothers in 0-6 months. To clarify the steady-state mechanism of iodine metabolism in pregnancy-milk during special physiological periods with different iodine exposure levels, research ideas and related research results can also provide references for the determination of other nutrient requirements.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Nutritional Requirements
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
dietary intervention
During the iodine balance period of pregnant women, seaweed was added to lunch on the 4-6 days of the experiment, and the iodine content was about 200 μg.
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Pregnant women:
* Aged 18-40, who have lived in the area for ≥5 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);
* Aged 18-40, who have lived in the area for ≥5 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);
Exclusion Criteria
Pregnant women:
* 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;
* Iodized drugs or contrast agents have been used;
* 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;
* Iodized drugs or contrast agents have been used;
Minimum Eligible Age
1 Day
Maximum Eligible Age
40 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tianjin Medical University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wanqi Zhang
professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ling Zhang
Role: PRINCIPAL_INVESTIGATOR
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Yanling Wang
Role: PRINCIPAL_INVESTIGATOR
Gansu Provincial Center for Disease Control and Prevention
Xiaomei Yao
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Laixiang Lin
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Zuoliang Dong
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Yiming Shen
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Chenchen Wang
Role: PRINCIPAL_INVESTIGATOR
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Wenxing Guo
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Ziyun Pan
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gansu Provincial Center for Disease Control and Prevention
Lanzhou, , China
Site Status
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Ürümqi, , China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
Gao M, Chen W, Sun H, Fan L, Wang W, Du C, Chen Y, Lin L, Pearce EN, Shen J, Cheng Y, Wang C, Zhang W. Excessive iodine intake is associated with formation of thyroid nodules in pregnant Chinese women. Nutr Res. 2019 Jun;66:61-67. doi: 10.1016/j.nutres.2019.02.009. Epub 2019 Mar 6.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Sang Z, Wei W, Zhao N, Zhang G, Chen W, Liu H, Shen J, Liu J, Yan Y, Zhang W. Thyroid dysfunction during late gestation is associated with excessive iodine intake in pregnant women. J Clin Endocrinol Metab. 2012 Aug;97(8):E1363-9. doi: 10.1210/jc.2011-3438. Epub 2012 Jun 5.
Reference Type
BACKGROUND
Shi X, Han C, Li C, Mao J, Wang W, Xie X, Li C, Xu B, Meng T, Du J, Zhang S, Gao Z, Zhang X, Fan C, Shan Z, Teng W. Optimal and safe upper limits of iodine intake for early pregnancy in iodine-sufficient regions: a cross-sectional study of 7190 pregnant women in China. J Clin Endocrinol Metab. 2015 Apr;100(4):1630-8. doi: 10.1210/jc.2014-3704. Epub 2015 Jan 28.
Reference Type
BACKGROUND
Yang L, Li M, Liu X, Wu M, Zhang J, Zhao L, Ding G, Yang X. Evaluation of Iodine Nutritional Status Among Pregnant Women in China. Thyroid. 2020 Mar;30(3):443-450. doi: 10.1089/thy.2019.0001.
Reference Type
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.
Reference Type
BACKGROUND
Andersson M, Braegger CP. The Role of Iodine for Thyroid Function in Lactating Women and Infants. Endocr Rev. 2021 Nov 17:bnab029. doi: 10.1210/endrev/bnab029. Online ahead of print. Erratum In: Endocr Rev. 2022 May 12;43(3):610.
Reference Type
BACKGROUND
Stravik M, Gustin K, Barman M, Skroder H, Sandin A, Wold AE, Sandberg AS, Kippler M, Vahter M. Infant Iodine and Selenium Status in Relation to Maternal Status and Diet During Pregnancy and Lactation. Front Nutr. 2021 Dec 17;8:733602. doi: 10.3389/fnut.2021.733602. eCollection 2021.
Reference Type
BACKGROUND
Zimmermann MB. The adverse effects of mild-to-moderate iodine deficiency during pregnancy and childhood: a review. Thyroid. 2007 Sep;17(9):829-35. doi: 10.1089/thy.2007.0108.
Reference Type
BACKGROUND
Naess S, Markhus MW, Strand TA, Kjellevold M, Dahl L, Stokland AM, Nedrebo BG, Aakre I. Iodine Nutrition and Iodine Supplement Initiation in Association with Thyroid Function in Mildly-to-Moderately Iodine-Deficient Pregnant and Postpartum Women. J Nutr. 2021 Oct 1;151(10):3187-3196. doi: 10.1093/jn/nxab224.
Reference Type
BACKGROUND
Zhang H, Wu M, Yang L, Wu J, Hu Y, Han J, Gu Y, Li X, Wang H, Ma L, Yang X. Evaluation of median urinary iodine concentration cut-off for defining iodine deficiency in pregnant women after a long term USI in China. Nutr Metab (Lond). 2019 Sep 9;16:62. doi: 10.1186/s12986-019-0381-4. eCollection 2019.
Reference Type
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.
Reference Type
BACKGROUND
Semba RD, Delange F. Iodine in human milk: perspectives for infant health. Nutr Rev. 2001 Aug;59(8 Pt 1):269-78. doi: 10.1111/j.1753-4887.2001.tb05512.x.
Reference Type
BACKGROUND
Nazeri P, Mirmiran P, Shiva N, Mehrabi Y, Mojarrad M, Azizi F. Iodine nutrition status in lactating mothers residing in countries with mandatory and voluntary iodine fortification programs: an updated systematic review. Thyroid. 2015 Jun;25(6):611-20. doi: 10.1089/thy.2014.0491. Epub 2015 May 14.
Reference Type
BACKGROUND
Chen Y, Gao M, Bai Y, Hao Y, Chen W, Cui T, Guo W, Pan Z, Lin L, Wang C, Shen J, Zhang W. Variation of iodine concentration in breast milk and urine in exclusively breastfeeding women and their infants during the first 24 wk after childbirth. Nutrition. 2020 Mar;71:110599. doi: 10.1016/j.nut.2019.110599. Epub 2019 Sep 23.
Reference Type
BACKGROUND
Azizi F, Smyth P. Breastfeeding and maternal and infant iodine nutrition. Clin Endocrinol (Oxf). 2009 May;70(5):803-9. doi: 10.1111/j.1365-2265.2008.03442.x. Epub 2008 Oct 6.
Reference Type
BACKGROUND
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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Teng D, Yang W, Shi X, Li Y, Ba J, Chen B, Du J, He L, Lai 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, Shan Z, Teng W. An Inverse Relationship Between Iodine Intake and Thyroid Antibodies: A National Cross-Sectional Survey in Mainland China. Thyroid. 2020 Nov;30(11):1656-1665. doi: 10.1089/thy.2020.0037. Epub 2020 Jul 23.
Reference Type
BACKGROUND
Lee YA, Cho SW, Sung HK, Kim K, Song YS, Moon SJ, Oh JW, Ju DL, Choi S, Song SH, Cheon GJ, Park YJ, Shin CH, Park SK, Jun JK, Chung JK. Effects of Maternal Iodine Status during Pregnancy and Lactation on Maternal Thyroid Function and Offspring Growth and Development: A Prospective Study Protocol for the Ideal Breast Milk Cohort. Endocrinol Metab (Seoul). 2018 Sep;33(3):395-402. doi: 10.3803/EnM.2018.33.3.395.
Reference Type
BACKGROUND
Rillema JA, Hill MA. Prolactin regulation of the pendrin-iodide transporter in the mammary gland. Am J Physiol Endocrinol Metab. 2003 Jan;284(1):E25-8. doi: 10.1152/ajpendo.00383.2002. Epub 2002 Sep 11.
Reference Type
BACKGROUND
Dror DK, Allen LH. Iodine in Human Milk: A Systematic Review. Adv Nutr. 2018 May 1;9(suppl_1):347S-357S. doi: 10.1093/advances/nmy020.
Reference Type
BACKGROUND
Kennett JE, Poletini MO, Fitch CA, Freeman ME. Antagonism of oxytocin prevents suckling- and estradiol-induced, but not progesterone-induced, secretion of prolactin. Endocrinology. 2009 May;150(5):2292-9. doi: 10.1210/en.2008-1611. Epub 2008 Dec 23.
Reference Type
BACKGROUND
Mizokami T, Fukata S, Hishinuma A, Kogai T, Hamada K, Maruta T, Higashi K, Tajiri J. Iodide Transport Defect and Breast Milk Iodine. Eur Thyroid J. 2016 Jul;5(2):145-8. doi: 10.1159/000446496. Epub 2016 May 27.
Reference Type
BACKGROUND
Al-Rasheed MM, Alzahrani AS, Macadam A, Overall A, Gard P, Dzimiri N. The potential role of the sodium iodide symporter gene polymorphism in the development of differentiated thyroid cancer. Gene. 2015 Nov 10;572(2):163-8. doi: 10.1016/j.gene.2015.07.009. Epub 2015 Jul 6.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NSFC-8223000919
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Assessing Exclusive Breastfeeding Practice
NCT05959460
COMPLETED
Domperidone on the Composition of Preterm Breastmilk Using a Human Milk Mid-infrared Spectroscopy Analyzer
NCT06830226
ENROLLING_BY_INVITATION
Bone Accrual and Hormones in Response to Lactation
NCT01563094
COMPLETED
Breast Milk Zinc Transfer to Appropriate- and Small-for-gestational-age Bangladeshi Infants
NCT01728766
COMPLETED
The Effect of Gravity on the Occurrence of Lactational Mastitis
NCT05207241
UNKNOWN
The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
NCT01388582
COMPLETED
PHASE4
Metabolism, Breastmilk, and Microbiome
NCT03522597
COMPLETED
Metabolomic Profile in Breastfed Late Preterm Infants
NCT06052592
COMPLETED
Breastfeeding Intervention Study
NCT02016586
COMPLETED
NA
Breast Milk Hormones and Early Infant Growth of Women With Gestational Diabetes Mellitus
NCT03145649
COMPLETED
Stress and Breast Milk Study In the Neonatal Intensive Care Unit
NCT03617549
COMPLETED
Evaluation of the Nutrients Composition of Breast Milk of Chinese Lactating Mothers and Their Nutrition Intake
NCT01971671
COMPLETED
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections
NCT06833554
RECRUITING
NA
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression
NCT01463202
COMPLETED
PHASE4
Lead Mobilization & Bone Turnover in Pregnancy/Lactation
NCT00011726
COMPLETED
At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
NCT06691932
RECRUITING
Provider Approaches to Improved Rates of Infant Nutrition and Growth Study
NCT00643253
COMPLETED
PHASE3
Impact of Antepartum Breast Milk Expression on Breastfeeding Rates in Patients With Gestational Diabetes Mellitus
NCT07128433
NOT_YET_RECRUITING
NA
Mother-Infant Cohort Study in Malaysia and China
NCT04919265
RECRUITING
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
NCT06929091
RECRUITING
NA
RE104 Clinical Lactation Study
NCT06659263
COMPLETED
PHASE1
Establishing Global Reference Values for Human Milk
NCT03254329
UNKNOWN
Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition
NCT06319079
RECRUITING
NA
Developing and Testing an Educational Intervention Through Technological Platform to Support Exclusive Breastfeeding
NCT05979571
NOT_YET_RECRUITING
NA