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Study on the Compensatory Mechanism of Iodine Nutrition and the Optimal Intake Level of Lactating Women

9. august 2020 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02101-02117
        • Rekruttering
        • Boston University School of Medicine; Iodine Global Network (IGN)
        • Kontakt:
      • Beijing, Kina
        • Rekruttering
        • Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
        • Kontakt:
        • Kontakt:
      • Shandong, Kina
        • Rekruttering
        • Shandong Institute of Endemic Disease Control and Prevention
        • Kontakt:
        • Kontakt:
      • Zurich, Schweiz
        • Rekruttering
        • Swiss federal institute of Technology (ETH)
        • Kontakt:
        • Underforsker:
          • Maria Andersson

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 dag til 40 år (Barn, Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: ZiYun Pan, Tianjin Medical University
  • Ledende efterforsker: JianQiang Lai, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
  • Ledende efterforsker: XueSong Wang, Shandong Institute of Endemic Disease Control and Prevention
  • Ledende efterforsker: YiFan Duan, Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention
  • Ledende efterforsker: GuiJun Tan, Tianjin Medical University
  • Ledende efterforsker: Wen Chen, Tianjin Medical University
  • Ledende efterforsker: YanTing Chen, Tianjin Medical University
  • Ledende efterforsker: 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)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2020

Primær færdiggørelse (Forventet)

31. december 2021

Studieafslutning (Forventet)

31. december 2024

Datoer for studieregistrering

Først indsendt

21. juli 2020

Først indsendt, der opfyldte QC-kriterier

27. juli 2020

Først opslået (Faktiske)

30. juli 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. august 2020

Sidst verificeret

1. august 2020

Mere information

Begreber relateret til denne undersøgelse

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