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Nutritional RequirementsNCT04419103

Study on Physiologic Requirement and Dietary Recommended Nutrient Intake (RNI) of Iodine in Children

An observational study of Nutritional Requirements, run by Tianjin Medical University at 1 site in China.

Completed

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

Official record
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Trial summary

Iodine is one of essential micronutrient for human, both iodine deficiency and excess will be harmful for human health. Children is the susceptible population to iodine nutrition, and studies show that even mild iodine deficiency would affect the growth and development of children, so it is urgent to identify the… Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Nutritional Requirements
How many people
600 participants
Where
1 siteChina
Study dates
1 Jul 2019to 1 Dec 2021
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 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 7-11 years old Primary school students who in grades 2, 3, 4 and 5 are the research subjects.They were recruited in Shandong.

Who may be able to join

  • Normal body mass index and thyroid function have not been treated for thyroid disease have not used amiodarone and other drugs (including iodine supplements) during the investigation have no major diseases and family history have lived in the local area for more than 5 years

Who cannot join

  • Long-term low-protein long-term low-heat energy malnutrition

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong Institute for Endemic Disease Control and Research

    Dezhou, Shandong

Other trials in China

About this study

Official title: Study on Physiologic Requirement and Dietary Recommended Nutrient

Iodine is one of essential micronutrient for human, both iodine deficiency and excess will be harmful for human health. Children is the susceptible population to iodine nutrition, and studies show that even mild iodine deficiency would affect the growth and development of children, so it is urgent to identify the dietary recommended nutrient intake (RNI) of iodine for children to guide children scientifically and safely supplement iodine. There are few studies about the dietary recommended nutrient intake (RNI) of iodine in children, and present data are old and outdated.

Read the detailed description

Based on the investigators'previous study on upper safe level of iodine on children from areas with high iodine in drinking water, this study will conduct an epidemiological study on 600 children living in areas with high water iodine content but the actual iodine content in participants' drinking water is not so high, while no supply of iodized salt.

Meanwhile, in order to get iodine dietary recommended nutrient intake (RNI) values of children. The investigators will conduct a iodine balance experiment on children with sufficient iodine nutrition. We will randomly select thirty healthy students for a three-day iodine balance experiment from the cross-sectional study. The investigators will use the regression model to obtain an iodine intake value when children at"zero iodine"balance. Combine the study at population and individual level, the investigators will obtain data on dietary recommended nutrient intake (RNI) of iodine for Chinese children, to properly guide children iodine supplementation to avoid iodine deficiency, which also will provide data for the update of Chinese dietary reference intakes of iodine.

Being tested
no intervention
Keywords
nutrient, public nutrition, nutrition related diseases, nutrition epidemiology

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. urinary iodine concentration

    μg/L

    Measured: 2 weeks

  2. free triiodothyronine

    pmol/L

    Measured: 2 weeks

  3. water iodine intake

    μg/day

    Measured: 2 weeks

  4. diet iodine intake

    μg/day

    Measured: 2 weeks

  5. salt iodine concentration

    μg/L

    Measured: 2 weeks

  6. free thyroxine

    pmol/L

    Measured: 2 weeks

  7. thyroid-stimulating hormone

    mIU/L

    Measured: 2 weeks

  8. thyroperoxidase antibody

    IU/mL

    Measured: 2 weeks

  9. thyroglobulin antibody

    IU/mL

    Measured: 2 weeks

  10. urinary iodine excretion

    μg/day

    Measured: 2 weeks

  11. fecal iodine excretion

    μg/day

    Measured: 2 weeks

Timeline

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

  1. First posted5 Jun 2020
  2. Study start1 Jul 2019
  3. Primary completion1 Oct 2021
  4. Study completion1 Dec 2021

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419103
Sponsor's protocol ID
NSFC-81803223
Status last verified
Nov 2022
First submitted
1 Jun 2020
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sang Z, Chen W, Shen J, Tan L, Zhao N, Liu H, Wen S, Wei W, Zhang G, Zhang W. Long-term exposure to excessive iodine from water is associated with thyroid dysfunction in children. J Nutr. 2013 Dec;143(12):2038-43. doi: 10.3945/jn.113.179135. Epub 2013 Oct 9.

    PubMed 24108132

  • Brantsaeter AL, Knutsen HK, Johansen NC, Nyheim KA, Erlund I, Meltzer HM, Henjum S. Inadequate Iodine Intake in Population Groups Defined by Age, Life Stage and Vegetarian Dietary Practice in a Norwegian Convenience Sample. Nutrients. 2018 Feb 17;10(2):230. doi: 10.3390/nu10020230.

    PubMed 29462974

  • Pal N, Samanta SK, Chakraborty A, Chandra NK, Chandra AK. Interrelationship between iodine nutritional status of lactating mothers and their absolutely breast-fed infants in coastal districts of Gangetic West Bengal in India. Eur J Pediatr. 2018 Jan;177(1):39-45. doi: 10.1007/s00431-017-3025-6. Epub 2017 Oct 23.

    PubMed 29063209

  • Zimmermann MB, Andersson M. Update on iodine status worldwide. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):382-7. doi: 10.1097/MED.0b013e328357271a.

    PubMed 22892867

  • Delshad H, Mirmiran P, Abdollahi Z, Salehi F, Azizi F. Continuously sustained elimination of iodine deficiency: a quarter of a century success in the Islamic Republic of Iran. J Endocrinol Invest. 2018 Sep;41(9):1089-1095. doi: 10.1007/s40618-018-0838-8. Epub 2018 Feb 14.

    PubMed 29446011

  • Andersson M, Karumbunathan V, Zimmermann MB. Global iodine status in 2011 and trends over the past decade. J Nutr. 2012 Apr;142(4):744-50. doi: 10.3945/jn.111.149393. Epub 2012 Feb 29.

    PubMed 22378324

  • Murcia M, Espada M, Julvez J, Llop S, Lopez-Espinosa MJ, Vioque J, Basterrechea M, Riano I, Gonzalez L, Alvarez-Pedrerol M, Tardon A, Ibarluzea J, Rebagliato M. Iodine intake from supplements and diet during pregnancy and child cognitive and motor development: the INMA Mother and Child Cohort Study. J Epidemiol Community Health. 2018 Mar;72(3):216-222. doi: 10.1136/jech-2017-209830. Epub 2017 Dec 26.

    PubMed 29279360

  • Zimmermann MB, Ito Y, Hess SY, Fujieda K, Molinari L. High thyroid volume in children with excess dietary iodine intakes. Am J Clin Nutr. 2005 Apr;81(4):840-4. doi: 10.1093/ajcn/81.4.840.

    PubMed 15817861

  • 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

  • Aakre I, Strand TA, Moubarek K, Barikmo I, Henjum S. Associations between thyroid dysfunction and developmental status in children with excessive iodine status. PLoS One. 2017 Nov 22;12(11):e0187241. doi: 10.1371/journal.pone.0187241. eCollection 2017.

    PubMed 29166388

  • Calza L, Fernandez M, Giardino L. Cellular approaches to central nervous system remyelination stimulation: thyroid hormone to promote myelin repair via endogenous stem and precursor cells. J Mol Endocrinol. 2010 Jan;44(1):13-23. doi: 10.1677/JME-09-0067. Epub 2009 Jul 3.

    PubMed 19578096

  • Liu HL, Lam LT, Zeng Q, Han SQ, Fu G, Hou CC. Effects of drinking water with high iodine concentration on the intelligence of children in Tianjin, China. J Public Health (Oxf). 2009 Mar;31(1):32-8. doi: 10.1093/pubmed/fdn097. Epub 2008 Oct 23.

    PubMed 18952598

  • Malvaux P, Beckers C, De Visscher M. Iodine balance studies in nongoitrous children and in adolescents on low iodine intake. J Clin Endocrinol Metab. 1969 Jan;29(1):79-84. doi: 10.1210/jcem-29-1-79. No abstract available.

    PubMed 5762324

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional Requirements, run by Tianjin Medical University at 1 site 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 1 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 concentration (time frame: 2 weeks). The study lists 11 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 NCT04419103, which also lists 23 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 29 Nov 2022.

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