Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
9. srpna 2020 aktualizováno: Wanqi Zhang, Tianjin Medical University
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.
Přehled studie
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Očekávaný)
600
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: ying ye
- Telefonní číslo: 022-83336717
- E-mail: yeying@tmu.edu.cn
Studijní záloha kontaktů
- Jméno: WanQi Zhang, doctorate
- Telefonní číslo: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
Studijní místa
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02101-02117
- Nábor
- Boston University School of Medicine; Iodine Global Network (IGN)
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Kontakt:
- Elizabeth N Pearce
- Telefonní číslo: 617-414-1348
- E-mail: elizabeth.pearce@bmc.org
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Beijing, Čína
- Nábor
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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Kontakt:
- ying ye
- Telefonní číslo: 022-83336717
- E-mail: yeying@tmu.edu.cn
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Kontakt:
- WanQi Zhang
- Telefonní číslo: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
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Shandong, Čína
- Nábor
- Shandong Institute of Endemic Disease Control and Prevention
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Kontakt:
- Zhang WanQi
- Telefonní číslo: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
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Kontakt:
- Ye ying
- Telefonní číslo: 022-83336717
- E-mail: yeying@tmu.edu.cn
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Zurich, Švýcarsko
- Nábor
- Swiss federal institute of Technology (ETH)
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Kontakt:
- Michael B Zimmermann
- Telefonní číslo: +41-44-632-8657
- E-mail: michael.zimmermann@hest.ethz.ch
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Dílčí vyšetřovatel:
- Maria Andersson
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
1 den až 40 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
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
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Disposable random urine
Časové okno: baseline
|
μg/L
|
baseline
|
|
Venous blood
Časové okno: baseline
|
μg/L
|
baseline
|
|
Water iodine intake
Časové okno: baseline
|
μg/day
|
baseline
|
|
Salt iodine concentration
Časové okno: baseline
|
μg/day
|
baseline
|
|
Colostrum
Časové okno: 1 week
|
μg/L
|
1 week
|
|
Mother and child urine randomly at one time
Časové okno: 1 week
|
μg/L
|
1 week
|
|
Neonatal heel blood
Časové okno: 1 week
|
μg/L
|
1 week
|
|
Thyroglobulin(TG)
Časové okno: 1 week
|
ug/L
|
1 week
|
|
Thyroid-stimulating hormone
Časové okno: 1 week
|
mIU/L
|
1 week
|
|
Infant disposable random urine
Časové okno: 4 weeks
|
μg/L
|
4 weeks
|
|
Infant disposable random urine
Časové okno: 24 weeks
|
μg/L
|
24 weeks
|
|
Infant disposable random urine
Časové okno: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Časové okno: 4 weeks
|
μg/L
|
4 weeks
|
|
24 h urine
Časové okno: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Časové okno: 24 weeks
|
μg/L
|
24 weeks
|
|
Urinary iodine excretion
Časové okno: 4 weeks
|
μg/day
|
4 weeks
|
|
Urinary iodine excretion
Časové okno: 12 weeks
|
μg/day
|
12 weeks
|
|
Urinary iodine excretion
Časové okno: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk output
Časové okno: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk output
Časové okno: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk output
Časové okno: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk iodine excretion
Časové okno: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk iodine excretion
Časové okno: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk iodine excretion
Časové okno: 24 weeks
|
μg/day
|
24 weeks
|
|
Average iodine intake
Časové okno: 4 weeks
|
μg/day
|
4 weeks
|
|
Average iodine intake
Časové okno: 12 weeks
|
μg/day
|
12 weeks
|
|
Average iodine intake
Časové okno: 24 weeks
|
μg/day
|
24 weeks
|
|
Thyroid volume
Časové okno: 1 week
|
cm³
|
1 week
|
|
Thyroid volume
Časové okno: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid volume
Časové okno: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid volume
Časové okno: 24 weeks
|
cm³
|
24 weeks
|
|
Thyroid nodule
Časové okno: 1 week
|
cm³
|
1 week
|
|
Thyroid nodule
Časové okno: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid nodule
Časové okno: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid nodule
Časové okno: 24 weeks
|
cm³
|
24 weeks
|
|
Dried blood spot(DBS)
Časové okno: 3 days
|
μg/L
|
3 days
|
|
Dried blood spot(DBS)
Časové okno: 12 weeks
|
μg/L
|
12 weeks
|
|
Diet iodine intake
Časové okno: 1 week
|
μg/day
|
1 week
|
|
Fecal iodine excretion
Časové okno: 1 week
|
μg/day
|
1 week
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: ZiYun Pan, Tianjin Medical University
- Vrchní vyšetřovatel: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Vrchní vyšetřovatel: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
- Vrchní vyšetřovatel: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Vrchní vyšetřovatel: GuiJun Tan, Tianjin Medical University
- Vrchní vyšetřovatel: Wen Chen, Tianjin Medical University
- Vrchní vyšetřovatel: YanTing Chen, Tianjin Medical University
- Vrchní vyšetřovatel: Min Gao, Tianjin Medical University
- Studijní židle: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH)
- Studijní židle: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN)
- Studijní židle: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
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- 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.
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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.
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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.
- Zimmermann MB, Moretti D, Chaouki N, Torresani T. Development of a dried whole-blood spot thyroglobulin assay and its evaluation as an indicator of thyroid status in goitrous children receiving iodized salt. Am J Clin Nutr. 2003 Jun;77(6):1453-8. doi: 10.1093/ajcn/77.6.1453.
- 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.
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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.
- Yan YQ, Dong ZL, Dong L, Wang FR, Yang XM, Jin XY, Lin LX, Sun YN, Chen ZP. Trimester- and method-specific reference intervals for thyroid tests in pregnant Chinese women: methodology, euthyroid definition and iodine status can influence the setting of reference intervals. Clin Endocrinol (Oxf). 2011 Feb;74(2):262-9. doi: 10.1111/j.1365-2265.2010.03910.x.
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2020
Primární dokončení (Očekávaný)
31. prosince 2021
Dokončení studie (Očekávaný)
31. prosince 2024
Termíny zápisu do studia
První předloženo
21. července 2020
První předloženo, které splnilo kritéria kontroly kvality
27. července 2020
První zveřejněno (Aktuální)
30. července 2020
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. srpna 2020
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. srpna 2020
Naposledy ověřeno
1. srpna 2020
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- NSFC-8191001159
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .