AzTrials
AzTrials

PregnancyNCT02586220

Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

An observational study of Pregnancy and Iodine Deficiency, run by qingya tang at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn… Read more about this study

Who is it for?
Ages 22 to 35 years, women only
Conditions the study is for
Pregnancy, Iodine Deficiency
How many people
250 participants
Where
2 sitesChina
Study dates
Aug 2015to Jul 2016
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 22 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: 250 pregnant women recruited from antenatal outpatient clinics in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, China.

Who may be able to join

  • 22-35 years,
  • 28-32 weeks' gestation,

Who cannot join

  • a known history of thyroid disease in the non-pregnant state and previous.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine

    Shanghai, Shanghai Municipality, 200092

  • Xinhua Hospital

    Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Read the detailed description

Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Design: prospective cohort study

Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.

Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.

What participants receive

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

Study groups in NCT02586220
Study groupRoleWhat they receive
normal pregnant women150 normal pregnant women (28-32 weeks' gestation)
pregnant women with gestational100 pregnant women with gestational diabetes (28-32 weeks' gestation)

What is being measured

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

  1. urinary iodine (UI) concentrations

    Measured: up to three months

Secondary outcomes (2)

  1. thyroid stimulating hormone level of newborns

    Measured: up to three months

  2. daily iodine intake of pregnant women

    Daily iodine intake was estimated using the total diet study approach

    Measured: up to three months

Timeline

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

  1. First posted26 Oct 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2016
  4. Study completionJul 2016

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
Cohort
Time perspective
Prospective
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02586220
Sponsor's protocol ID
XHEC-C-2015-003-2
Status last verified
Mar 2020
First submitted
23 Sep 2015
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Luo Y, Kawashima A, Ishido Y, Yoshihara A, Oda K, Hiroi N, Ito T, Ishii N, Suzuki K. Iodine excess as an environmental risk factor for autoimmune thyroid disease. Int J Mol Sci. 2014 Jul 21;15(7):12895-912. doi: 10.3390/ijms150712895.

    PubMed 25050783

  • Konig F, Andersson M, Hotz K, Aeberli I, Zimmermann MB. Ten repeat collections for urinary iodine from spot samples or 24-hour samples are needed to reliably estimate individual iodine status in women. J Nutr. 2011 Nov;141(11):2049-54. doi: 10.3945/jn.111.144071. Epub 2011 Sep 14.

    PubMed 21918061

  • Als C, Helbling A, Peter K, Haldimann M, Zimmerli B, Gerber H. Urinary iodine concentration follows a circadian rhythm: a study with 3023 spot urine samples in adults and children. J Clin Endocrinol Metab. 2000 Apr;85(4):1367-9. doi: 10.1210/jcem.85.4.6496.

    PubMed 10770167

  • Busnardo B, Nacamulli D, Zambonin L, Mian C, Piccolo M, Girelli ME. Restricted intraindividual urinary iodine concentration variability in nonfasting subjects. Eur J Clin Nutr. 2006 Mar;60(3):421-5. doi: 10.1038/sj.ejcn.1602334.

    PubMed 16391581

  • Knudsen N, Christiansen E, Brandt-Christensen M, Nygaard B, Perrild H. Age- and sex-adjusted iodine/creatinine ratio. A new standard in epidemiological surveys? Evaluation of three different estimates of iodine excretion based on casual urine samples and comparison to 24 h values. Eur J Clin Nutr. 2000 Apr;54(4):361-3. doi: 10.1038/sj.ejcn.1600935.

    PubMed 10745289

  • Zimmermann MB. Iodine deficiency. Endocr Rev. 2009 Jun;30(4):376-408. doi: 10.1210/er.2009-0011. Epub 2009 May 21.

    PubMed 19460960

  • Vejbjerg P, Knudsen N, Perrild H, Laurberg P, Carle A, Pedersen IB, Rasmussen LB, Ovesen L, Jorgensen T. Thyroglobulin as a marker of iodine nutrition status in the general population. Eur J Endocrinol. 2009 Sep;161(3):475-81. doi: 10.1530/EJE-09-0262. Epub 2009 Jun 25.

    PubMed 19556382

  • van den Briel T, West CE, Hautvast JG, Vulsma T, de Vijlder JJ, Ategbo EA. Serum thyroglobulin and urinary iodine concentration are the most appropriate indicators of iodine status and thyroid function under conditions of increasing iodine supply in schoolchildren in Benin. J Nutr. 2001 Oct;131(10):2701-6. doi: 10.1093/jn/131.10.2701.

    PubMed 11584093

  • Travers CA, Guttikonda K, Norton CA, Lewis PR, Mollart LJ, Wiley V, Wilcken B, Eastman CJ, Boyages SC. Iodine status in pregnant women and their newborns: are our babies at risk of iodine deficiency? Med J Aust. 2006 Jun 19;184(12):617-20. doi: 10.5694/j.1326-5377.2006.tb00417.x.

    PubMed 16803441

  • Leung AM, Braverman LE. Consequences of excess iodine. Nat Rev Endocrinol. 2014 Mar;10(3):136-42. doi: 10.1038/nrendo.2013.251. Epub 2013 Dec 17.

    PubMed 24342882

  • Katz PM, Leung AM, Braverman LE, Pearce EN, Tomlinson G, He X, Vertes J, Okun N, Walfish PG, Feig DS. Iodine nutrition during pregnancy in Toronto, Canada. Endocr Pract. 2013 Mar-Apr;19(2):206-11. doi: 10.4158/EP12193.OR.

    PubMed 23186967

  • WHO Secretariat; Andersson M, de Benoist B, Delange F, Zupan J. Prevention and control of iodine deficiency in pregnant and lactating women and in children less than 2-years-old: conclusions and recommendations of the Technical Consultation. Public Health Nutr. 2007 Dec;10(12A):1606-11. doi: 10.1017/S1368980007361004. No abstract available.

    PubMed 18053287

  • Caldwell KL, Makhmudov A, Ely E, Jones RL, Wang RY. Iodine status of the U.S. population, National Health and Nutrition Examination Survey, 2005-2006 and 2007-2008. Thyroid. 2011 Apr;21(4):419-27. doi: 10.1089/thy.2010.0077.

    PubMed 21323596

  • Perrine CG, Herrick K, Serdula MK, Sullivan KM. Some subgroups of reproductive age women in the United States may be at risk for iodine deficiency. J Nutr. 2010 Aug;140(8):1489-94. doi: 10.3945/jn.109.120147. Epub 2010 Jun 16.

    PubMed 20554903

  • Sullivan KM, Perrine CG, Pearce EN, Caldwell KL. Monitoring the iodine status of pregnant women in the United States. Thyroid. 2013 Apr;23(4):520-1. doi: 10.1089/thy.2012.0217. No abstract available.

    PubMed 23157653

Questions about this trial

What is this clinical trial studying?

An observational study of Pregnancy and Iodine Deficiency, run by qingya tang 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Mar 2020. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urinary iodine (UI) concentrations (time frame: up to three months). 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 NCT02586220, which also lists 30 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 25 Mar 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in