Displacement of Iodine Balance Value During Pregnancy and the Mechanism of Breast Iodine Homeostasis During Lactation

NCT05730803 | Not Yet Recruiting

• 1 other identifier: NSFC-8223000919
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

In order to solve the bottleneck problems of"zero balance displacement"and"large variation of breastmilk"in the study of iodine EAR of pregnant women, lactating women and infants, firstly, this study intends to clarify the rate of metabolism and distribution of iodine during pregnancy by 125I tracer, SPECT/CT in vivo small animal imaging and γ counting study. Then, the iodine balance study in rats was conducted to verify the degree of "zero balance value displacement"caused by the difference of iodine absorption and store in different organs and tissues under different iodine exposure levels, so as to determine the iodine selection conditions of subjects in the population experiment. To determine the EAR of pregnant women by optimizing the population iodine balance experiment. Secondly, we proposed to study the regulatory mechanism of NIS and Pendrin in the mammary gland of lactating rats under different iodine nutrition levels to clarify the range of breastmilk iodine compensation. Mammary cell experiments intend to clarify the mutual regulations of iodine nutrition, oestrogen, and NIS and Pendrin. Based on the results of animal and cellular experiments, and the effect of genetic, oestrogen and iodine status were considered, a cross-sectional study of lactating women was conducted to determine the normal reference range of breastmilk iodine after screening out the people with abnormal indicators. This study will solve the bottleneck problems and difficulties in the iodine RNI research for pregnant women, lactating women and infants, found the iodine nutritional compensatory mechanism under special physiology, and provide the scientific basis for obtaining the accurate EAR basic data and the revision of iodine DRIs.

Conditions

Nutritional Requirements

Keywords

nutrition of special population; nutrient; trace element iodine; zero balance displacement; large variation of breastmilk

Outcome Measures

Primary Outcomes (21)

• urine iodine concentration

  μg/L

  pregnancy 1-40 weeks

• Free thyroxine

  pmol/L

  pregnancy 1-40 weeks

• Free triiodothyronine

  pmol/L

  pregnancy 1-40 weeks

• Thyroglobulin(TG)

  ug/L

  pregnancy 1-40 weeks

• Thyroid-stimulating hormone

  mIU/L

  pregnancy 1-40 weeks

• Salt iodine concentration

  μg/day

  pregnancy 1-40 weeks

• Urinary iodine excretion

  μg/day

  pregnancy 1-40 weeks

• Fecal iodine excretion

  μg/day

  pregnancy 1-40 weeks

• Dietary iodine intake

  μg/day

  pregnancy 1-40 weeks

• Water iodine intake

  ug/day

  pregnancy 1-40 weeks

• Thyroid peroxidase antibody

  IU/mL

  pregnancy 1-40 weeks

• Thyroglobulin antibody

  IU/mL

  pregnancy 1-40 weeks

• Milk iodine excretion

  μg/day

  Postpartum 0-6 months

• Milk Iodine concentration

  μg/L

  Postpartum 0-6 months

• Thyroid volume

  cm³

  Postpartum 0-6 months

• Na+/I- symporter

  mRNA

  Postpartum 0-6 months

• Pendrin

  mRNA

  Postpartum 0-6 months

• estrogen

  pmol/L

  Postpartum 0-6 months

• progesterone

  pmol/L

  Postpartum 0-6 months

• oxytocin

  ng/L

  Postpartum 0-6 months

• prolactin

  pg/MI

  Postpartum 0-6 months

Secondary Outcomes (1)

• Milk output

  Postpartum 0-6 months

Interventions

dietary intervention OTHER

During the iodine balance period of pregnant women, seaweed was added to lunch on the 4-6 days of the experiment, and the iodine content was about 200 μg.

Eligibility Criteria

• Age: 1 Day - 40 Years
• Sex: female
• 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), all from Tianjin, Xinjiang and Gansu.

You may qualify if:

• Pregnant women:
• Aged 18-40, who have lived in the area for ≥5 year;
• Single pregnancy;
• Those who have no special dietary habits;
• Lactating woman:
• Breastfeeding a child;
• Normal thyroid function during pregnancy;
• Term delivery (38-42 weeks of gestation);

You may not qualify if:

• Pregnant women:
• Smoking or drinking;
• Iodized drugs or contrast agents have been used in the past year;
• A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc
• Lactating woman:
• A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;
• Iodized drugs or contrast agents have been used;

Sponsors & Collaborators

• Tianjin Medical University: lead

Study Sites (2)

Gansu Provincial Center for Disease Control and Prevention

Lanzhou, China

Location

Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

Ürümqi, China

Location

Related Publications (30)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine, breast milk, faeces

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Ling Zhang

  Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Yanling Wang

  Gansu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Xiaomei Yao

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Laixiang Lin

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Zuoliang Dong

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Yiming Shen

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Chenchen Wang

  Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Wenxing Guo

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

• Ziyun Pan

  Tianjin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanqi Zhang, docotorate

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: February 2, 2023
• First Posted: February 16, 2023
• Study Start: February 17, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)