Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women
9. August 2020 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Voraussichtlich)
600
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: ying ye
- Telefonnummer: 022-83336717
- E-Mail: yeying@tmu.edu.cn
Studieren Sie die Kontaktsicherung
- Name: WanQi Zhang, doctorate
- Telefonnummer: 022-83336595
- E-Mail: wqzhang@tmu.edu.cn
Studienorte
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Beijing, China
- Rekrutierung
- Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
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Kontakt:
- ying ye
- Telefonnummer: 022-83336717
- E-Mail: yeying@tmu.edu.cn
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Kontakt:
- WanQi Zhang
- Telefonnummer: 022-83336595
- E-Mail: wqzhang@tmu.edu.cn
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Shandong, China
- Rekrutierung
- Shandong Institute of Endemic Disease Control and Prevention
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Kontakt:
- Zhang WanQi
- Telefonnummer: 022-83336595
- E-Mail: wqzhang@tmu.edu.cn
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Kontakt:
- Ye ying
- Telefonnummer: 022-83336717
- E-Mail: yeying@tmu.edu.cn
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Zurich, Schweiz
- Rekrutierung
- Swiss federal institute of Technology (ETH)
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Kontakt:
- Michael B Zimmermann
- Telefonnummer: +41-44-632-8657
- E-Mail: michael.zimmermann@hest.ethz.ch
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Unterermittler:
- Maria Andersson
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02101-02117
- Rekrutierung
- Boston University School of Medicine; Iodine Global Network (IGN)
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Kontakt:
- Elizabeth N Pearce
- Telefonnummer: 617-414-1348
- E-Mail: elizabeth.pearce@bmc.org
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
1 Tag bis 40 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Disposable random urine
Zeitfenster: baseline
|
μg/L
|
baseline
|
|
Venous blood
Zeitfenster: baseline
|
μg/L
|
baseline
|
|
Water iodine intake
Zeitfenster: baseline
|
μg/day
|
baseline
|
|
Salt iodine concentration
Zeitfenster: baseline
|
μg/day
|
baseline
|
|
Colostrum
Zeitfenster: 1 week
|
μg/L
|
1 week
|
|
Mother and child urine randomly at one time
Zeitfenster: 1 week
|
μg/L
|
1 week
|
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Neonatal heel blood
Zeitfenster: 1 week
|
μg/L
|
1 week
|
|
Thyroglobulin(TG)
Zeitfenster: 1 week
|
ug/L
|
1 week
|
|
Thyroid-stimulating hormone
Zeitfenster: 1 week
|
mIU/L
|
1 week
|
|
Infant disposable random urine
Zeitfenster: 4 weeks
|
μg/L
|
4 weeks
|
|
Infant disposable random urine
Zeitfenster: 24 weeks
|
μg/L
|
24 weeks
|
|
Infant disposable random urine
Zeitfenster: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Zeitfenster: 4 weeks
|
μg/L
|
4 weeks
|
|
24 h urine
Zeitfenster: 12 weeks
|
μg/L
|
12 weeks
|
|
24 h urine
Zeitfenster: 24 weeks
|
μg/L
|
24 weeks
|
|
Urinary iodine excretion
Zeitfenster: 4 weeks
|
μg/day
|
4 weeks
|
|
Urinary iodine excretion
Zeitfenster: 12 weeks
|
μg/day
|
12 weeks
|
|
Urinary iodine excretion
Zeitfenster: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk output
Zeitfenster: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk output
Zeitfenster: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk output
Zeitfenster: 24 weeks
|
μg/day
|
24 weeks
|
|
Milk iodine excretion
Zeitfenster: 4 weeks
|
μg/day
|
4 weeks
|
|
Milk iodine excretion
Zeitfenster: 12 weeks
|
μg/day
|
12 weeks
|
|
Milk iodine excretion
Zeitfenster: 24 weeks
|
μg/day
|
24 weeks
|
|
Average iodine intake
Zeitfenster: 4 weeks
|
μg/day
|
4 weeks
|
|
Average iodine intake
Zeitfenster: 12 weeks
|
μg/day
|
12 weeks
|
|
Average iodine intake
Zeitfenster: 24 weeks
|
μg/day
|
24 weeks
|
|
Thyroid volume
Zeitfenster: 1 week
|
cm³
|
1 week
|
|
Thyroid volume
Zeitfenster: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid volume
Zeitfenster: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid volume
Zeitfenster: 24 weeks
|
cm³
|
24 weeks
|
|
Thyroid nodule
Zeitfenster: 1 week
|
cm³
|
1 week
|
|
Thyroid nodule
Zeitfenster: 4 weeks
|
cm³
|
4 weeks
|
|
Thyroid nodule
Zeitfenster: 12 weeks
|
cm³
|
12 weeks
|
|
Thyroid nodule
Zeitfenster: 24 weeks
|
cm³
|
24 weeks
|
|
Dried blood spot(DBS)
Zeitfenster: 3 days
|
μg/L
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3 days
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Dried blood spot(DBS)
Zeitfenster: 12 weeks
|
μg/L
|
12 weeks
|
|
Diet iodine intake
Zeitfenster: 1 week
|
μg/day
|
1 week
|
|
Fecal iodine excretion
Zeitfenster: 1 week
|
μg/day
|
1 week
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: ZiYun Pan, Tianjin Medical University
- Hauptermittler: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hauptermittler: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
- Hauptermittler: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
- Hauptermittler: GuiJun Tan, Tianjin Medical University
- Hauptermittler: Wen Chen, Tianjin Medical University
- Hauptermittler: YanTing Chen, Tianjin Medical University
- Hauptermittler: Min Gao, Tianjin Medical University
- Studienstuhl: Michael B Zimmermann, doctorate, Swiss federal institute of Technology (ETH)
- Studienstuhl: Elizabeth N Pearce, doctorate, Boston University School of Medicine; Iodine Global Network (IGN)
- Studienstuhl: Maria Andersson, doctorate, Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
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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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- 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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- 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.
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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.
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- 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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- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2020
Primärer Abschluss (Voraussichtlich)
31. Dezember 2021
Studienabschluss (Voraussichtlich)
31. Dezember 2024
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2020
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. Juli 2020
Zuerst gepostet (Tatsächlich)
30. Juli 2020
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. August 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. August 2020
Zuletzt verifiziert
1. August 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- NSFC-8191001159
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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