Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
9. august 2020 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Forventet)
600
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: ying ye
- Telefonnummer: 022-83336717
- E-post: yeying@tmu.edu.cn
Studer Kontakt Backup
- Navn: WanQi Zhang, doctorate
- Telefonnummer: 022-83336595
- E-post: wqzhang@tmu.edu.cn
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02101-02117
- Rekruttering
- Boston University School of Medicine; Iodine Global Network (IGN)
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Ta kontakt med:
- Elizabeth N Pearce
- Telefonnummer: 617-414-1348
- E-post: elizabeth.pearce@bmc.org
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Beijing, Kina
- Rekruttering
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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Ta kontakt med:
- ying ye
- Telefonnummer: 022-83336717
- E-post: yeying@tmu.edu.cn
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Ta kontakt med:
- WanQi Zhang
- Telefonnummer: 022-83336595
- E-post: wqzhang@tmu.edu.cn
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Shandong, Kina
- Rekruttering
- Shandong Institute of Endemic Disease Control and Prevention
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Ta kontakt med:
- Zhang WanQi
- Telefonnummer: 022-83336595
- E-post: wqzhang@tmu.edu.cn
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Ta kontakt med:
- Ye ying
- Telefonnummer: 022-83336717
- E-post: yeying@tmu.edu.cn
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Zurich, Sveits
- Rekruttering
- Swiss federal institute of Technology (ETH)
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Ta kontakt med:
- Michael B Zimmermann
- Telefonnummer: +41-44-632-8657
- E-post: michael.zimmermann@hest.ethz.ch
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Underetterforsker:
- Maria Andersson
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 dag til 40 år (Barn, Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disposable random urine
Tidsramme: baseline
|
μg/L
|
baseline
|
|
Venous blood
Tidsramme: baseline
|
μg/L
|
baseline
|
|
Water iodine intake
Tidsramme: baseline
|
μg/day
|
baseline
|
|
Salt iodine concentration
Tidsramme: baseline
|
μg/day
|
baseline
|
|
Colostrum
Tidsramme: 1 week
|
μg/L
|
1 week
|
|
Mother and child urine randomly at one time
Tidsramme: 1 week
|
μg/L
|
1 week
|
|
Neonatal heel blood
Tidsramme: 1 week
|
μg/L
|
1 week
|
|
Thyroglobulin(TG)
Tidsramme: 1 week
|
ug/L
|
1 week
|
|
Thyroid-stimulating hormone
Tidsramme: 1 week
|
mIU/L
|
1 week
|
|
Infant disposable random urine
Tidsramme: 4 weeks
|
μg/L
|
4 weeks
|
|
Infant disposable random urine
Tidsramme: 24 weeks
|
μg/L
|
24 weeks
|
|
Infant disposable random urine
Tidsramme: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Tidsramme: 4 weeks
|
μg/L
|
4 weeks
|
|
24 h urine
Tidsramme: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Tidsramme: 24 weeks
|
μg/L
|
24 weeks
|
|
Urinary iodine excretion
Tidsramme: 4 weeks
|
μg/day
|
4 weeks
|
|
Urinary iodine excretion
Tidsramme: 12 weeks
|
μg/day
|
12 weeks
|
|
Urinary iodine excretion
Tidsramme: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk output
Tidsramme: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk output
Tidsramme: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk output
Tidsramme: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk iodine excretion
Tidsramme: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk iodine excretion
Tidsramme: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk iodine excretion
Tidsramme: 24 weeks
|
μg/day
|
24 weeks
|
|
Average iodine intake
Tidsramme: 4 weeks
|
μg/day
|
4 weeks
|
|
Average iodine intake
Tidsramme: 12 weeks
|
μg/day
|
12 weeks
|
|
Average iodine intake
Tidsramme: 24 weeks
|
μg/day
|
24 weeks
|
|
Thyroid volume
Tidsramme: 1 week
|
cm³
|
1 week
|
|
Thyroid volume
Tidsramme: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid volume
Tidsramme: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid volume
Tidsramme: 24 weeks
|
cm³
|
24 weeks
|
|
Thyroid nodule
Tidsramme: 1 week
|
cm³
|
1 week
|
|
Thyroid nodule
Tidsramme: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid nodule
Tidsramme: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid nodule
Tidsramme: 24 weeks
|
cm³
|
24 weeks
|
|
Dried blood spot(DBS)
Tidsramme: 3 days
|
μg/L
|
3 days
|
|
Dried blood spot(DBS)
Tidsramme: 12 weeks
|
μg/L
|
12 weeks
|
|
Diet iodine intake
Tidsramme: 1 week
|
μg/day
|
1 week
|
|
Fecal iodine excretion
Tidsramme: 1 week
|
μg/day
|
1 week
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: ZiYun Pan, Tianjin Medical University
- Hovedetterforsker: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hovedetterforsker: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
- Hovedetterforsker: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hovedetterforsker: GuiJun Tan, Tianjin Medical University
- Hovedetterforsker: Wen Chen, Tianjin Medical University
- Hovedetterforsker: YanTing Chen, Tianjin Medical University
- Hovedetterforsker: Min Gao, Tianjin Medical University
- Studiestol: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH)
- Studiestol: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN)
- Studiestol: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- Zhang Y, Du C, Wang W, Chen W, Shao P, Wang C, Leng J, Shen J, Tan L, Zhang W. Effect of maternal and neonatal factors on neonatal thyroid stimulating hormone: Results from a population-based prospective cohort study in China. J Trace Elem Med Biol. 2018 Sep;49:151-156. doi: 10.1016/j.jtemb.2018.05.008. Epub 2018 May 25.
- 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.
- 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.
- 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.
- Suzuki K, Kimura H, Wu H, Kudo N, Kim WB, Suzuki S, Yoshida A, Caturegli P, Kohn LD. Excess iodide decreases transcription of NIS and VEGF genes in rat FRTL-5 thyroid cells. Biochem Biophys Res Commun. 2010 Mar 5;393(2):286-90. doi: 10.1016/j.bbrc.2010.01.123. Epub 2010 Feb 2.
- 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.
- Van Sande J, Dequanter D, Lothaire P, Massart C, Dumont JE, Erneux C. Thyrotropin stimulates the generation of inositol 1,4,5-trisphosphate in human thyroid cells. J Clin Endocrinol Metab. 2006 Mar;91(3):1099-107. doi: 10.1210/jc.2005-1324. Epub 2005 Dec 29.
- 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.
- Ryan J, Curran CE, Hennessy E, Newell J, Morris JC, Kerin MJ, Dwyer RM. The sodium iodide symporter (NIS) and potential regulators in normal, benign and malignant human breast tissue. PLoS One. 2011 Jan 19;6(1):e16023. doi: 10.1371/journal.pone.0016023.
- 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.
- 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. doi: 10.1089/105072503322401078.
- Wang W, Sun Y, Zhang M, Zhang Y, Chen W, Tan L, Shen J, Zhao Z, Lan S, Zhang W. Breast milk and infant iodine status during the first 12 weeks of lactation in Tianjin City, China. Asia Pac J Clin Nutr. 2018;27(2):393-398. doi: 10.6133/apjcn.062017.03.
- 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.
- 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.
- Ingenbleek Y, Malvaux P. Iodine balance studies in protein-calorie malnutrition. Arch Dis Child. 1974 Apr;49(4):305-9. doi: 10.1136/adc.49.4.305.
- Knudsen N, Bulow I, Jorgensen T, Perrild H, Ovesen L, Laurberg P. Serum Tg--a sensitive marker of thyroid abnormalities and iodine deficiency in epidemiological studies. J Clin Endocrinol Metab. 2001 Aug;86(8):3599-603. doi: 10.1210/jcem.86.8.7772.
- 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.
- Mao IF, Ko YC, Chen ML. The stability of iodine in human sweat. Jpn J Physiol. 1990;40(5):693-700. doi: 10.2170/jjphysiol.40.693.
- Swanson CA, Zimmermann MB, Skeaff S, Pearce EN, Dwyer JT, Trumbo PR, Zehaluk C, Andrews KW, Carriquiry A, Caldwell KL, Egan SK, Long SE, Bailey RL, Sullivan KM, Holden JM, Betz JM, Phinney KW, Brooks SP, Johnson CL, Haggans CJ. Summary of an NIH workshop to identify research needs to improve the monitoring of iodine status in the United States and to inform the DRI. J Nutr. 2012 Jun;142(6):1175S-85S. doi: 10.3945/jn.111.156448. Epub 2012 May 2.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2020
Primær fullføring (Forventet)
31. desember 2021
Studiet fullført (Forventet)
31. desember 2024
Datoer for studieregistrering
Først innsendt
21. juli 2020
Først innsendt som oppfylte QC-kriteriene
27. juli 2020
Først lagt ut (Faktiske)
30. juli 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. august 2020
Sist bekreftet
1. august 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- NSFC-8191001159
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .