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

NCT04492657 | Unknown

• 1 other identifier: NSFC-8191001159
• Study Type: observational
• Target: 600
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Nutritional Requirements

Keywords

public nutrition; nutrition of special population; lactating women and infants; physiological compensatory mechanism; iodine balance study

Outcome Measures

Primary Outcomes (39)

• Disposable random urine

  μg/L

  baseline

• Venous blood

  μg/L

  baseline

• Water iodine intake

  μg/day

  baseline

• Salt iodine concentration

  μg/day

  baseline

• Colostrum

  μg/L

  1 week

• Mother and child urine randomly at one time

  μg/L

  1 week

• Neonatal heel blood

  μg/L

  1 week

• Thyroglobulin(TG)

  ug/L

  1 week

• Thyroid-stimulating hormone

  mIU/L

  1 week

• Infant disposable random urine

  μg/L

  4 weeks

• Infant disposable random urine

  μg/L

  24 weeks

• Infant disposable random urine

  μg/L

  12 weeks

• 24 h urine

  μg/L

  4 weeks

• 24 h urine

  μg/L

  12 weeks

• 24 h urine

  μg/L

  24 weeks

• Urinary iodine excretion

  μg/day

  4 weeks

• Urinary iodine excretion

  μg/day

  12 weeks

• Urinary iodine excretion

  μg/day

  24 weeks

• Milk output

  μg/day

  4 weeks

• Milk output

  μg/day

  12 weeks

• Milk output

  μg/day

  24 weeks

• Milk iodine excretion

  μg/day

  4 weeks

• Milk iodine excretion

  μg/day

  12 weeks

• Milk iodine excretion

  μg/day

  24 weeks

• Average iodine intake

  μg/day

  4 weeks

• Average iodine intake

  μg/day

  12 weeks

• Average iodine intake

  μg/day

  24 weeks

• Thyroid volume

  cm³

  1 week

• Thyroid volume

  cm³

  4 weeks

• Thyroid volume

  cm³

  12 weeks

• Thyroid volume

  cm³

  24 weeks

• Thyroid nodule

  cm³

  1 week

• Thyroid nodule

  cm³

  4 weeks

• Thyroid nodule

  cm³

  12 weeks

• Thyroid nodule

  cm³

  24 weeks

• Dried blood spot(DBS)

  μg/L

  3 days

• Dried blood spot(DBS)

  μg/L

  12 weeks

• Diet iodine intake

  μg/day

  1 week

• Fecal iodine excretion

  μg/day

  1 week

Interventions

no intervention OTHER

Natural exposure of iodine.

Eligibility Criteria

• Age: 1 Day - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (4)

Boston University School of Medicine; Iodine Global Network (IGN)

Boston, Massachusetts, 02101-02117, United States

RECRUITING

Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention

Beijing, China

RECRUITING

Shandong Institute of Endemic Disease Control and Prevention

Shandong, China

RECRUITING

Swiss federal institute of Technology (ETH)

Zurich, Switzerland

RECRUITING

Related Publications (51)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

blood,urine,breast milk

Study Officials

• JianQiang Lai

  Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• XueSong Wang

  Shandong Institute of Endemic Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• YiFan Duan

  Institute of Nutrition and Health, Chinese Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• GuiJun Tan

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Wen Chen

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• YanTing Chen

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Min Gao

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• ZiYun Pan

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Michael B Zimmermann, doctorate

  Swiss federal institute of Technology (ETH)

  STUDY CHAIR

• Elizabeth N Pearce, doctorate

  Boston University School of Medicine; Iodine Global Network (IGN)

  STUDY CHAIR

• Maria Andersson, doctorate

  Swiss federal institute of Technology (ETH); Iodine Global Network (IGN)

  STUDY CHAIR

Central Study Contacts

WanQi Zhang, doctorate

CONTACT

022-83336595; wqzhang@tmu.edu.cn

ying Ye

CONTACT

022-83336717; yeying@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 30, 2020
• Study Start: January 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); US (1); CH (1)