Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
9 agosto 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
600
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: ying ye
- Numero di telefono: 022-83336717
- Email: yeying@tmu.edu.cn
Backup dei contatti dello studio
- Nome: WanQi Zhang, doctorate
- Numero di telefono: 022-83336595
- Email: wqzhang@tmu.edu.cn
Luoghi di studio
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Beijing, Cina
- Reclutamento
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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Contatto:
- ying ye
- Numero di telefono: 022-83336717
- Email: yeying@tmu.edu.cn
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Contatto:
- WanQi Zhang
- Numero di telefono: 022-83336595
- Email: wqzhang@tmu.edu.cn
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Shandong, Cina
- Reclutamento
- Shandong Institute of Endemic Disease Control and Prevention
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Contatto:
- Zhang WanQi
- Numero di telefono: 022-83336595
- Email: wqzhang@tmu.edu.cn
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Contatto:
- Ye ying
- Numero di telefono: 022-83336717
- Email: yeying@tmu.edu.cn
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02101-02117
- Reclutamento
- Boston University School of Medicine; Iodine Global Network (IGN)
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Contatto:
- Elizabeth N Pearce
- Numero di telefono: 617-414-1348
- Email: elizabeth.pearce@bmc.org
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Zurich, Svizzera
- Reclutamento
- Swiss federal institute of Technology (ETH)
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Contatto:
- Michael B Zimmermann
- Numero di telefono: +41-44-632-8657
- Email: michael.zimmermann@hest.ethz.ch
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Sub-investigatore:
- Maria Andersson
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 giorno a 40 anni (Bambino, Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Disposable random urine
Lasso di tempo: baseline
|
μg/L
|
baseline
|
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Venous blood
Lasso di tempo: baseline
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μg/L
|
baseline
|
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Water iodine intake
Lasso di tempo: baseline
|
μg/day
|
baseline
|
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Salt iodine concentration
Lasso di tempo: baseline
|
μg/day
|
baseline
|
|
Colostrum
Lasso di tempo: 1 week
|
μg/L
|
1 week
|
|
Mother and child urine randomly at one time
Lasso di tempo: 1 week
|
μg/L
|
1 week
|
|
Neonatal heel blood
Lasso di tempo: 1 week
|
μg/L
|
1 week
|
|
Thyroglobulin(TG)
Lasso di tempo: 1 week
|
ug/L
|
1 week
|
|
Thyroid-stimulating hormone
Lasso di tempo: 1 week
|
mIU/L
|
1 week
|
|
Infant disposable random urine
Lasso di tempo: 4 weeks
|
μg/L
|
4 weeks
|
|
Infant disposable random urine
Lasso di tempo: 24 weeks
|
μg/L
|
24 weeks
|
|
Infant disposable random urine
Lasso di tempo: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Lasso di tempo: 4 weeks
|
μg/L
|
4 weeks
|
|
24 h urine
Lasso di tempo: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Lasso di tempo: 24 weeks
|
μg/L
|
24 weeks
|
|
Urinary iodine excretion
Lasso di tempo: 4 weeks
|
μg/day
|
4 weeks
|
|
Urinary iodine excretion
Lasso di tempo: 12 weeks
|
μg/day
|
12 weeks
|
|
Urinary iodine excretion
Lasso di tempo: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk output
Lasso di tempo: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk output
Lasso di tempo: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk output
Lasso di tempo: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk iodine excretion
Lasso di tempo: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk iodine excretion
Lasso di tempo: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk iodine excretion
Lasso di tempo: 24 weeks
|
μg/day
|
24 weeks
|
|
Average iodine intake
Lasso di tempo: 4 weeks
|
μg/day
|
4 weeks
|
|
Average iodine intake
Lasso di tempo: 12 weeks
|
μg/day
|
12 weeks
|
|
Average iodine intake
Lasso di tempo: 24 weeks
|
μg/day
|
24 weeks
|
|
Thyroid volume
Lasso di tempo: 1 week
|
cm³
|
1 week
|
|
Thyroid volume
Lasso di tempo: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid volume
Lasso di tempo: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid volume
Lasso di tempo: 24 weeks
|
cm³
|
24 weeks
|
|
Thyroid nodule
Lasso di tempo: 1 week
|
cm³
|
1 week
|
|
Thyroid nodule
Lasso di tempo: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid nodule
Lasso di tempo: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid nodule
Lasso di tempo: 24 weeks
|
cm³
|
24 weeks
|
|
Dried blood spot(DBS)
Lasso di tempo: 3 days
|
μg/L
|
3 days
|
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Dried blood spot(DBS)
Lasso di tempo: 12 weeks
|
μg/L
|
12 weeks
|
|
Diet iodine intake
Lasso di tempo: 1 week
|
μg/day
|
1 week
|
|
Fecal iodine excretion
Lasso di tempo: 1 week
|
μg/day
|
1 week
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: ZiYun Pan, Tianjin Medical University
- Investigatore principale: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Investigatore principale: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
- Investigatore principale: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Investigatore principale: GuiJun Tan, Tianjin Medical University
- Investigatore principale: Wen Chen, Tianjin Medical University
- Investigatore principale: YanTing Chen, Tianjin Medical University
- Investigatore principale: Min Gao, Tianjin Medical University
- Cattedra di studio: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH)
- Cattedra di studio: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN)
- Cattedra di studio: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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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- 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.
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- 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.
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- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2020
Completamento primario (Anticipato)
31 dicembre 2021
Completamento dello studio (Anticipato)
31 dicembre 2024
Date di iscrizione allo studio
Primo inviato
21 luglio 2020
Primo inviato che soddisfa i criteri di controllo qualità
27 luglio 2020
Primo Inserito (Effettivo)
30 luglio 2020
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 agosto 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 agosto 2020
Ultimo verificato
1 agosto 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- NSFC-8191001159
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .