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Nutritional RequirementsNCT05730803

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

An observational study of Nutritional Requirements, run by Tianjin Medical University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Nutritional Requirements
What is being tested?
dietary intervention
How many people
1,200 participants
Where
2 sitesChina
Study dates
17 Feb 2023to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 40 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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);

Who cannot join

  • 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;

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wanqi Zhang, docotorate contact

022-83336595

wqzhang@tmu.edu.cn

Ying Ye contact

022-83336717

yeying@tmu.edu.cn

China2 sites

  • Gansu Provincial Center for Disease Control and Prevention

    Lanzhou

    Wanqi Zhang, 022-83336595, wqzhang@tmu.edu.cn

    Ying Ye, 022-83336717, yeying@tmu.edu.cn

  • Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention

    Ürümqi

    Wanqi Zhang, 022-83336595, wqzhang@tmu.edu.cn

    Ying Ye, 022-83336717, yeying@tmu.edu.cn

Other trials in China

About this study

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

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.

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dietary interventionOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. urine iodine concentration

    μg/L

    Measured: pregnancy 1-40 weeks

  2. Free thyroxine

    pmol/L

    Measured: pregnancy 1-40 weeks

  3. Free triiodothyronine

    pmol/L

    Measured: pregnancy 1-40 weeks

  4. Thyroglobulin(TG)

    ug/L

    Measured: pregnancy 1-40 weeks

  5. Thyroid-stimulating hormone

    mIU/L

    Measured: pregnancy 1-40 weeks

  6. Salt iodine concentration

    μg/day

    Measured: pregnancy 1-40 weeks

  7. Urinary iodine excretion

    μg/day

    Measured: pregnancy 1-40 weeks

  8. Fecal iodine excretion

    μg/day

    Measured: pregnancy 1-40 weeks

  9. Dietary iodine intake

    μg/day

    Measured: pregnancy 1-40 weeks

  10. Water iodine intake

    ug/day

    Measured: pregnancy 1-40 weeks

  11. Thyroid peroxidase antibody

    IU/mL

    Measured: pregnancy 1-40 weeks

  12. Thyroglobulin antibody

    IU/mL

    Measured: pregnancy 1-40 weeks

  13. Milk iodine excretion

    μg/day

    Measured: Postpartum 0-6 months

  14. Milk Iodine concentration

    μg/L

    Measured: Postpartum 0-6 months

  15. Thyroid volume

    cm³

    Measured: Postpartum 0-6 months

  16. Na+/I- symporter

    mRNA

    Measured: Postpartum 0-6 months

  17. Pendrin

    mRNA

    Measured: Postpartum 0-6 months

  18. estrogen

    pmol/L

    Measured: Postpartum 0-6 months

  19. progesterone

    pmol/L

    Measured: Postpartum 0-6 months

  20. oxytocin

    ng/L

    Measured: Postpartum 0-6 months

  21. prolactin

    pg/MI

    Measured: Postpartum 0-6 months

Secondary outcomes (1)

  1. Milk output

    μg/day

    Measured: Postpartum 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start17 Feb 2023 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730803
Sponsor's protocol ID
NSFC-8223000919
Status last verified
Feb 2023
First submitted
2 Feb 2023
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stinca S, Andersson M, Herter-Aeberli I, Chabaa L, Cherkaoui M, El Ansari N, Aboussad A, Weibel S, Zimmermann MB. Moderate-to-Severe Iodine Deficiency in the "First 1000 Days" Causes More Thyroid Hypofunction in Infants Than in Pregnant or Lactating Women. J Nutr. 2017 Apr;147(4):589-595. doi: 10.3945/jn.116.244665. Epub 2017 Feb 15.

    PubMed 28202636

  • Gao M, Chen W, Sun H, Fan L, Wang W, Du C, Chen Y, Lin L, Pearce EN, Shen J, Cheng Y, Wang C, Zhang W. Excessive iodine intake is associated with formation of thyroid nodules in pregnant Chinese women. Nutr Res. 2019 Jun;66:61-67. doi: 10.1016/j.nutres.2019.02.009. Epub 2019 Mar 6.

    PubMed 30979661

  • Pearce EN, Lazarus JH, Moreno-Reyes R, Zimmermann MB. Consequences of iodine deficiency and excess in pregnant women: an overview of current knowns and unknowns. Am J Clin Nutr. 2016 Sep;104 Suppl 3(Suppl 3):918S-23S. doi: 10.3945/ajcn.115.110429. Epub 2016 Aug 17.

    PubMed 27534632

  • Sang Z, Wang PP, Yao Z, Shen J, Halfyard B, Tan L, Zhao N, Wu Y, Gao S, Tan J, Liu J, Chen Z, Zhang W. Exploration of the safe upper level of iodine intake in euthyroid Chinese adults: a randomized double-blind trial. Am J Clin Nutr. 2012 Feb;95(2):367-73. doi: 10.3945/ajcn.111.028001. Epub 2011 Dec 28.

    PubMed 22205314

  • Chen W, Li X, Wu Y, Bian J, Shen J, Jiang W, Tan L, Wang X, Wang W, Pearce EN, Zimmermann MB, Carriquiry AL, Zhang W. Associations between iodine intake, thyroid volume, and goiter rate in school-aged Chinese children from areas with high iodine drinking water concentrations. Am J Clin Nutr. 2017 Jan;105(1):228-233. doi: 10.3945/ajcn.116.139725. Epub 2016 Dec 7.

    PubMed 27927635

  • Chen W, Zhang Y, Hao Y, Wang W, Tan L, Bian J, Pearce EN, Zimmermann MB, Shen J, Zhang W. Adverse effects on thyroid of Chinese children exposed to long-term iodine excess: optimal and safe Tolerable Upper Intake Levels of iodine for 7- to 14-y-old children. Am J Clin Nutr. 2018 May 1;107(5):780-788. doi: 10.1093/ajcn/nqy011.

    PubMed 29722836

  • Sang Z, Wei W, Zhao N, Zhang G, Chen W, Liu H, Shen J, Liu J, Yan Y, Zhang W. Thyroid dysfunction during late gestation is associated with excessive iodine intake in pregnant women. J Clin Endocrinol Metab. 2012 Aug;97(8):E1363-9. doi: 10.1210/jc.2011-3438. Epub 2012 Jun 5.

    PubMed 22669304

  • Shi X, Han C, Li C, Mao J, Wang W, Xie X, Li C, Xu B, Meng T, Du J, Zhang S, Gao Z, Zhang X, Fan C, Shan Z, Teng W. Optimal and safe upper limits of iodine intake for early pregnancy in iodine-sufficient regions: a cross-sectional study of 7190 pregnant women in China. J Clin Endocrinol Metab. 2015 Apr;100(4):1630-8. doi: 10.1210/jc.2014-3704. Epub 2015 Jan 28.

    PubMed 25629356

  • Yang L, Li M, Liu X, Wu M, Zhang J, Zhao L, Ding G, Yang X. Evaluation of Iodine Nutritional Status Among Pregnant Women in China. Thyroid. 2020 Mar;30(3):443-450. doi: 10.1089/thy.2019.0001.

    PubMed 31964276

  • Tan L, Tian X, Wang W, Guo X, Sang Z, Li X, Zhang P, Sun Y, Tang C, Xu Z, Shen J, Zhang W. Exploration of the appropriate recommended nutrient intake of iodine in healthy Chinese women: an iodine balance experiment. Br J Nutr. 2019 Mar 14;121(5):519-528. doi: 10.1017/S0007114518003653. Epub 2018 Dec 11.

    PubMed 30526700

  • Stravik M, Gustin K, Barman M, Skroder H, Sandin A, Wold AE, Sandberg AS, Kippler M, Vahter M. Infant Iodine and Selenium Status in Relation to Maternal Status and Diet During Pregnancy and Lactation. Front Nutr. 2021 Dec 17;8:733602. doi: 10.3389/fnut.2021.733602. eCollection 2021.

    PubMed 34988107

  • Zimmermann MB. The adverse effects of mild-to-moderate iodine deficiency during pregnancy and childhood: a review. Thyroid. 2007 Sep;17(9):829-35. doi: 10.1089/thy.2007.0108.

    PubMed 17956157

  • Naess S, Markhus MW, Strand TA, Kjellevold M, Dahl L, Stokland AM, Nedrebo BG, Aakre I. Iodine Nutrition and Iodine Supplement Initiation in Association with Thyroid Function in Mildly-to-Moderately Iodine-Deficient Pregnant and Postpartum Women. J Nutr. 2021 Oct 1;151(10):3187-3196. doi: 10.1093/jn/nxab224.

    PubMed 34255063

  • Zhang H, Wu M, Yang L, Wu J, Hu Y, Han J, Gu Y, Li X, Wang H, Ma L, Yang X. Evaluation of median urinary iodine concentration cut-off for defining iodine deficiency in pregnant women after a long term USI in China. Nutr Metab (Lond). 2019 Sep 9;16:62. doi: 10.1186/s12986-019-0381-4. eCollection 2019.

    PubMed 31516542

  • Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27.

    PubMed 27465383

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Requirements, run by Tianjin Medical University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wanqi Zhang, docotorate (022-83336595, wqzhang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urine iodine concentration (time frame: pregnancy 1-40 weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730803, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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