Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
9 augustus 2020 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Verwacht)
600
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: ying ye
- Telefoonnummer: 022-83336717
- E-mail: yeying@tmu.edu.cn
Studie Contact Back-up
- Naam: WanQi Zhang, doctorate
- Telefoonnummer: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
Studie Locaties
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Beijing, China
- Werving
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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Contact:
- ying ye
- Telefoonnummer: 022-83336717
- E-mail: yeying@tmu.edu.cn
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Contact:
- WanQi Zhang
- Telefoonnummer: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
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Shandong, China
- Werving
- Shandong Institute of Endemic Disease Control and Prevention
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Contact:
- Zhang WanQi
- Telefoonnummer: 022-83336595
- E-mail: wqzhang@tmu.edu.cn
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Contact:
- Ye ying
- Telefoonnummer: 022-83336717
- E-mail: yeying@tmu.edu.cn
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02101-02117
- Werving
- Boston University School of Medicine; Iodine Global Network (IGN)
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Contact:
- Elizabeth N Pearce
- Telefoonnummer: 617-414-1348
- E-mail: elizabeth.pearce@bmc.org
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Zurich, Zwitserland
- Werving
- Swiss federal institute of Technology (ETH)
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Contact:
- Michael B Zimmermann
- Telefoonnummer: +41-44-632-8657
- E-mail: michael.zimmermann@hest.ethz.ch
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Onderonderzoeker:
- Maria Andersson
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 dag tot 40 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Disposable random urine
Tijdsspanne: baseline
|
μg/L
|
baseline
|
|
Venous blood
Tijdsspanne: baseline
|
μg/L
|
baseline
|
|
Water iodine intake
Tijdsspanne: baseline
|
μg/day
|
baseline
|
|
Salt iodine concentration
Tijdsspanne: baseline
|
μg/day
|
baseline
|
|
Colostrum
Tijdsspanne: 1 week
|
μg/L
|
1 week
|
|
Mother and child urine randomly at one time
Tijdsspanne: 1 week
|
μg/L
|
1 week
|
|
Neonatal heel blood
Tijdsspanne: 1 week
|
μg/L
|
1 week
|
|
Thyroglobulin(TG)
Tijdsspanne: 1 week
|
ug/L
|
1 week
|
|
Thyroid-stimulating hormone
Tijdsspanne: 1 week
|
mIU/L
|
1 week
|
|
Infant disposable random urine
Tijdsspanne: 4 weeks
|
μg/L
|
4 weeks
|
|
Infant disposable random urine
Tijdsspanne: 24 weeks
|
μg/L
|
24 weeks
|
|
Infant disposable random urine
Tijdsspanne: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Tijdsspanne: 4 weeks
|
μg/L
|
4 weeks
|
|
24 h urine
Tijdsspanne: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Tijdsspanne: 24 weeks
|
μg/L
|
24 weeks
|
|
Urinary iodine excretion
Tijdsspanne: 4 weeks
|
μg/day
|
4 weeks
|
|
Urinary iodine excretion
Tijdsspanne: 12 weeks
|
μg/day
|
12 weeks
|
|
Urinary iodine excretion
Tijdsspanne: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk output
Tijdsspanne: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk output
Tijdsspanne: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk output
Tijdsspanne: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk iodine excretion
Tijdsspanne: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk iodine excretion
Tijdsspanne: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk iodine excretion
Tijdsspanne: 24 weeks
|
μg/day
|
24 weeks
|
|
Average iodine intake
Tijdsspanne: 4 weeks
|
μg/day
|
4 weeks
|
|
Average iodine intake
Tijdsspanne: 12 weeks
|
μg/day
|
12 weeks
|
|
Average iodine intake
Tijdsspanne: 24 weeks
|
μg/day
|
24 weeks
|
|
Thyroid volume
Tijdsspanne: 1 week
|
cm³
|
1 week
|
|
Thyroid volume
Tijdsspanne: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid volume
Tijdsspanne: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid volume
Tijdsspanne: 24 weeks
|
cm³
|
24 weeks
|
|
Thyroid nodule
Tijdsspanne: 1 week
|
cm³
|
1 week
|
|
Thyroid nodule
Tijdsspanne: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid nodule
Tijdsspanne: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid nodule
Tijdsspanne: 24 weeks
|
cm³
|
24 weeks
|
|
Dried blood spot(DBS)
Tijdsspanne: 3 days
|
μg/L
|
3 days
|
|
Dried blood spot(DBS)
Tijdsspanne: 12 weeks
|
μg/L
|
12 weeks
|
|
Diet iodine intake
Tijdsspanne: 1 week
|
μg/day
|
1 week
|
|
Fecal iodine excretion
Tijdsspanne: 1 week
|
μg/day
|
1 week
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: ZiYun Pan, Tianjin Medical University
- Hoofdonderzoeker: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hoofdonderzoeker: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
- Hoofdonderzoeker: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hoofdonderzoeker: GuiJun Tan, Tianjin Medical University
- Hoofdonderzoeker: Wen Chen, Tianjin Medical University
- Hoofdonderzoeker: YanTing Chen, Tianjin Medical University
- Hoofdonderzoeker: Min Gao, Tianjin Medical University
- Studie stoel: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH)
- Studie stoel: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN)
- Studie stoel: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
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- 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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- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2020
Primaire voltooiing (Verwacht)
31 december 2021
Studie voltooiing (Verwacht)
31 december 2024
Studieregistratiedata
Eerst ingediend
21 juli 2020
Eerst ingediend dat voldeed aan de QC-criteria
27 juli 2020
Eerst geplaatst (Werkelijk)
30 juli 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 augustus 2020
Laatste update ingediend die voldeed aan QC-criteria
9 augustus 2020
Laatst geverifieerd
1 augustus 2020
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- NSFC-8191001159
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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