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Nutritional RequirementsNCT04492657

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

An observational study of Nutritional Requirements, run by Tianjin Medical University at 4 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 40 yearsHealthy volunteers can take part
Conditions the study is for
Nutritional Requirements
How many people
600 participants
Where
4 sitesin 3 countries
Study dates
1 Jan 2020to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 3 countries.

WanQi Zhang, doctorate contact

022-83336595

wqzhang@tmu.edu.cn

ying Ye contact

022-83336717

yeying@tmu.edu.cn

4 sites in 3 countries

China2 sites, 2 recruiting

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

    Beijing

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

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

    Recruiting

  • Shandong Institute of Endemic Disease Control and Prevention

    Shandong

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

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

    Recruiting

Other trials in China

United States1 site, 1 recruiting

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

    Boston, Massachusetts, 02101-02117

    Elizabeth N Pearce, 617-414-1348, elizabeth.pearce@bmc.org

    Recruiting

Other trials in United States

Switzerland1 site, 1 recruiting

  • Swiss federal institute of Technology (ETH)

    Zurich

    Michael B Zimmermann, +41-44-632-8657, michael.zimmermann@hest.ethz.ch

    Maria Andersson

    Recruiting

Other trials in Switzerland

About this study

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.

Read the detailed description

Studies indicate lactating women and their infants are the most vulnerable population to the adverse effects of iodine deficiency and excess, and because of the complexity of the study of lactating mothers and infants and the difficulty of sample collection, it is proposed to overcome this problem with the help of the advanced dried blood spot technique and iodine balance study method from the panel of Iodine Global Network (IGN). Investigators intend to recruit 900 late pregnant women in Tianjin, Hebei and Shandong;then establishing a dynamic cohort of breastfeeding mother-infant to 6 months after delivery to investigate the physiological compensatory mechanism of iodine nutrition in lactating women with the combination of animal experiment; On the other hand, 180 exclusively breastfeeding mother and infants within postpartum 0-6 months, will be selected to participate the iodine balance study.

Optimized method of iodine balance experiment of infants by both foreign partner and Pro. Zhang's team will be adopted to obtain the first iodine balance value of Chinese lactating women and infants,providing the direct evidence for the revision of DRIs in lactating women and infants, and guide the lactating women proper iodine supplementation to meet the requirements of both mothers and infants.

Being tested
no intervention
Keywords
public nutrition, nutrition of special population, lactating women and infants, physiological compensatory mechanism, iodine balance study

What participants receive

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

  • no interventionOther

    Natural exposure of iodine.

What is being measured

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

  1. Disposable random urine

    μg/L

    Measured: baseline

  2. Venous blood

    μg/L

    Measured: baseline

  3. Water iodine intake

    μg/day

    Measured: baseline

  4. Salt iodine concentration

    μg/day

    Measured: baseline

  5. Colostrum

    μg/L

    Measured: 1 week

  6. Mother and child urine randomly at one time

    μg/L

    Measured: 1 week

  7. Neonatal heel blood

    μg/L

    Measured: 1 week

  8. Thyroglobulin(TG)

    ug/L

    Measured: 1 week

  9. Thyroid-stimulating hormone

    mIU/L

    Measured: 1 week

  10. Infant disposable random urine

    μg/L

    Measured: 4 weeks

  11. Infant disposable random urine

    μg/L

    Measured: 24 weeks

  12. Infant disposable random urine

    μg/L

    Measured: 12 weeks

  13. 24 h urine

    μg/L

    Measured: 4 weeks

  14. 24 h urine

    μg/L

    Measured: 12 weeks

  15. 24 h urine

    μg/L

    Measured: 24 weeks

  16. Urinary iodine excretion

    μg/day

    Measured: 4 weeks

  17. Urinary iodine excretion

    μg/day

    Measured: 12 weeks

  18. Urinary iodine excretion

    μg/day

    Measured: 24 weeks

  19. Milk output

    μg/day

    Measured: 4 weeks

  20. Milk output

    μg/day

    Measured: 12 weeks

  21. Milk output

    μg/day

    Measured: 24 weeks

  22. Milk iodine excretion

    μg/day

    Measured: 4 weeks

  23. Milk iodine excretion

    μg/day

    Measured: 12 weeks

  24. Milk iodine excretion

    μg/day

    Measured: 24 weeks

  25. Average iodine intake

    μg/day

    Measured: 4 weeks

  26. Average iodine intake

    μg/day

    Measured: 12 weeks

  27. Average iodine intake

    μg/day

    Measured: 24 weeks

  28. Thyroid volume

    cm³

    Measured: 1 week

  29. Thyroid volume

    cm³

    Measured: 4 weeks

  30. Thyroid volume

    cm³

    Measured: 12 weeks

  31. Thyroid volume

    cm³

    Measured: 24 weeks

  32. Thyroid nodule

    cm³

    Measured: 1 week

  33. Thyroid nodule

    cm³

    Measured: 4 weeks

  34. Thyroid nodule

    cm³

    Measured: 12 weeks

  35. Thyroid nodule

    cm³

    Measured: 24 weeks

  36. Dried blood spot(DBS)

    μg/L

    Measured: 3 days

  37. Dried blood spot(DBS)

    μg/L

    Measured: 12 weeks

  38. Diet iodine intake

    μg/day

    Measured: 1 week

  39. Fecal iodine excretion

    μg/day

    Measured: 1 week

Timeline

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

  1. First posted30 Jul 2020
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2024 (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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04492657
Sponsor's protocol ID
NSFC-8191001159
Status last verified
Aug 2020
First submitted
21 Jul 2020
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brough L, Thomson BM, Skeaff SA. Revisiting the Iodine Global Network's definition of iodine status by country. Br J Nutr. 2016 Jan 28;115(2):374-6. doi: 10.1017/S0007114515004389. Epub 2015 Dec 2. No abstract available.

    PubMed 26627636

  • Pearce EN, Andersson M, Zimmermann MB. Global iodine nutrition: Where do we stand in 2013? Thyroid. 2013 May;23(5):523-8. doi: 10.1089/thy.2013.0128. Epub 2013 Apr 18.

    PubMed 23472655

  • 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, Wu Y, Lin L, Tan L, Shen J, Pearce EN, Guo X, Wang W, Bian J, Jiang W, Zhang W. 24-Hour Urine Samples Are More Reproducible Than Spot Urine Samples for Evaluation of Iodine Status in School-Age Children. J Nutr. 2016 Jan;146(1):142-6. doi: 10.3945/jn.115.215806. Epub 2015 Nov 25.

    PubMed 26609173

  • Chen W, Zhang Q, Wu Y, Wang W, Wang X, Pearce EN, Tan L, Shen J, Zhang W. Shift of Reference Values for Thyroid Volume by Ultrasound in 8- to 13-Year-Olds with Sufficient Iodine Intake in China. Thyroid. 2019 Mar;29(3):405-411. doi: 10.1089/thy.2018.0412.

    PubMed 30696370

  • 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

  • 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

  • Pan Z, Cui T, Chen W, Gao S, Pearce EN, Wang W, Chen Y, Guo W, Tan L, Shen J, Zhang W. Serum iodine concentration in pregnant women and its association with urinary iodine concentration and thyroid function. Clin Endocrinol (Oxf). 2019 May;90(5):711-718. doi: 10.1111/cen.13945. Epub 2019 Mar 7.

    PubMed 30724372

  • Zhang Y, Du C, Wang W, Chen W, Shao P, Wang C, Leng J, Shen J, Tan L, Zhang W. Effect of maternal and neonatal factors on neonatal thyroid stimulating hormone: Results from a population-based prospective cohort study in China. J Trace Elem Med Biol. 2018 Sep;49:151-156. doi: 10.1016/j.jtemb.2018.05.008. Epub 2018 May 25.

    PubMed 29895366

  • Chen Y, Chen W, Du C, Fan L, Wang W, Gao M, Zhang Y, Cui T, Hao Y, Pearce EN, Wang C, Zhang W. Iodine Nutrition and Thyroid Function in Pregnant Women Exposed to Different Iodine Sources. Biol Trace Elem Res. 2019 Jul;190(1):52-59. doi: 10.1007/s12011-018-1530-8. Epub 2018 Oct 2.

    PubMed 30280309

  • Chen W, Sang Z, Tan L, Zhang S, Dong F, Chu Z, Wei W, Zhao N, Zhang G, Yao Z, Shen J, Zhang W. Neonatal thyroid function born to mothers living with long-term excessive iodine intake from drinking water. Clin Endocrinol (Oxf). 2015 Sep;83(3):399-404. doi: 10.1111/cen.12625. Epub 2014 Nov 5.

    PubMed 25280177

  • 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

  • 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

  • Bizhanova A, Kopp P. Minireview: The sodium-iodide symporter NIS and pendrin in iodide homeostasis of the thyroid. Endocrinology. 2009 Mar;150(3):1084-90. doi: 10.1210/en.2008-1437. Epub 2009 Feb 5.

    PubMed 19196800

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Requirements, run by Tianjin Medical University at 4 sites in 3 countries.

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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China, United States, Switzerland. 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?

Results are not available in the source record.

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

Contact WanQi Zhang, doctorate (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?

Disposable random urine (time frame: baseline). The study lists 39 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 NCT04492657, which also lists 52 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 11 Aug 2020.

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