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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age1-40
SponsorTianjin Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-40, who have lived in the area for ≥5 year;

Single pregnancy;

Those who have no special dietary habits;

Breastfeeding a child;

Disqualifiers

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

A history of thyroid disease, autoimmune disease, endocrine disease, heart disease, chronic disease or family hereditary disease, etc;

Trial population

Women in the third trimester (18-40 years old), lactating women (38-42 weeks of gestation), all from Tianjin, Xinjiang and Gansu.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • dietary intervention

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

urine iodine concentration

μg/L

Time frame
pregnancy 1-40 weeks
2

Free thyroxine

pmol/L

Time frame
pregnancy 1-40 weeks
3

Free triiodothyronine

pmol/L

Time frame
pregnancy 1-40 weeks
4

Thyroglobulin(TG)

ug/L

Time frame
pregnancy 1-40 weeks

Secondary outcomes

1

Milk output

μg/day

Time frame
Postpartum 0-6 months

Other outcomes

Sponsors and contacts

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