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

Sponsor

Tianjin Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05730803

Collaborator

(none)

1,200

Enrollment

Locations

58.4

Anticipated Duration (Months)

600

Patients Per Site

10.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutritional Requirements	Other: dietary intervention

Detailed Description

In this study, the absorption, distribution, storage and excretion of 125I in rats were observed by small animal imaging technology in vivo, so as to clarify the characteristics of iodine metabolism under different iodine exposure, and provide a basis for optimizing the experimental cycle of iodine balance experiment. The iodine balance experiment of rats during pregnancy was carried out, the iodine storage in different organs was detected to explain the phenomenon of "zero point balance value shift", and the population with iodine nutrition background was determined as the experimental objects in the iodine balance experiment. The optimized iodine balance experiment was further verified in the population, and the iodine EAR of pregnant women was explored to provide reference data for formulating the recommended iodine intake of pregnant women in China in the future. The expression difference of NIS and Pendrin in lactating rats with different iodine nutritional status was used to determine the range of milk iodine compensation. To determine the synergistic and independent effects of iodine level and estrogen on the expression of NIS and Pendrin in lactating mammary gland cells cultured in primary culture. Through a cross-section study of lactating women, the correlation between milk iodine level and NIS, Pendrin gene mutation, iodine exposure level and estrogen was discussed, the phenomenon of "huge milk iodine variation" was explained, the normal reference range of milk iodine was defined, and the basis was laid for further determination of iodine AI and EAR of lactating mothers in 0-6 months. To clarify the steady-state mechanism of iodine metabolism in pregnancy-milk during special physiological periods with different iodine exposure levels, research ideas and related research results can also provide references for the determination of other nutrient requirements.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Study on the Displacement of Iodine Balance Value During Pregnancy and the Mechanism of Breast Iodine Homeostasis During Lactation Under Different Iodine Exposure

Anticipated Study Start Date :

Feb 17, 2023

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

urine iodine concentration [pregnancy 1-40 weeks]
μg/L
Free thyroxine [pregnancy 1-40 weeks]
pmol/L
Free triiodothyronine [pregnancy 1-40 weeks]
pmol/L
Thyroglobulin(TG) [pregnancy 1-40 weeks]
ug/L
Thyroid-stimulating hormone [pregnancy 1-40 weeks]
mIU/L
Salt iodine concentration [pregnancy 1-40 weeks]
μg/day
Urinary iodine excretion [pregnancy 1-40 weeks]
μg/day
Fecal iodine excretion [pregnancy 1-40 weeks]
μg/day
Dietary iodine intake [pregnancy 1-40 weeks]
μg/day
Water iodine intake [pregnancy 1-40 weeks]
ug/day
Thyroid peroxidase antibody [pregnancy 1-40 weeks]
IU/mL
Thyroglobulin antibody [pregnancy 1-40 weeks]
IU/mL
Milk iodine excretion [Postpartum 0-6 months]
μg/day
Milk Iodine concentration [Postpartum 0-6 months]
μg/L
Thyroid volume [Postpartum 0-6 months]
cm³
Na+/I- symporter [Postpartum 0-6 months]
mRNA
Pendrin [Postpartum 0-6 months]
mRNA
estrogen [Postpartum 0-6 months]
pmol/L
progesterone [Postpartum 0-6 months]
pmol/L
oxytocin [Postpartum 0-6 months]
ng/L
prolactin [Postpartum 0-6 months]
pg/MI

Secondary Outcome Measures

Milk output [Postpartum 0-6 months]
μg/day

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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);

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gansu Provincial Center for Disease Control and Prevention	Lanzhou		China
2	Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention	Urumqi		China

Sponsors and Collaborators

Tianjin Medical University

Investigators

Principal Investigator: 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