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Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?

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ClinicalTrials.gov Identifier: NCT00505479
Recruitment Status : Unknown
Verified July 2007 by Zhejiang University.
Recruitment status was:  Recruiting
First Posted : July 23, 2007
Last Update Posted : July 23, 2007
Sponsor:
Information provided by:
Zhejiang University

Brief Summary:
Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Condition or disease
Congenital Hypothyroidism Pregnancy Iodine Deficiency

Detailed Description:

Iodine is an essential component of thyroid hormone, which is necessary for many metabolic processes as well as the maturation of the CNS. Deficiencies of iodine have deleterious effects on both pregnant women and infants. The iodine status of the population after implementation of the universal salt iodization program in Zhejiang province has not been known. This study was to determine whether pregnant women show evidence of iodine deficiency, and to examine the correlation between maternal urine iodine concentration and newborn thyroid function.

Healthy women at 12 weeks’ gestation and over from four different areas in Zhejiang province were enrolled to participate this program from May 2007 to May 2010. Women consented to provide urine samples and salt samples during pregnancy (12, 16, 24 weeks’ gestation and before delivery), and give permission to access their newborn’s TSH value. Urinary iodine concentration (UIC) was determined by ammonium persulfate digestion microplate method, and TSH was determined by a time resolved fluoro-immunoassay (TRFIA). The diagnostic standard for congenital hypothyroidism was: TSH ≥ 20 mU/L and declined FT4 levels. Compare the correlation to effects with different level of iodine content in salt, maternal UIC and neonatal TSH. Investigate the optimal level of iodine content in salt in different areas in ZheJiang province.


Study Type : Observational
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : May 2007
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothyroidism
U.S. FDA Resources





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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in Zhejiang province (and their newborns)

Exclusion Criteria:

  • Endocrine disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505479


Contacts
Contact: Zhengyan Zhao, M.D. 008657187061007 zhaozy@zju.edu.cn

Locations
China, Zhejiang
Children's Hospital Zhejiang University School of Medicine Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Zhengyan Zhao, M.D.    008657187061007    zhaozy@zju.edu.cn   
Principal Investigator: Zhengyan Zhao, M.D.         
Sponsors and Collaborators
Zhejiang University
Investigators
Study Director: zhengyan Zhao, M.D. Children's Hospital Zhejiang University School of Medicine

ClinicalTrials.gov Identifier: NCT00505479     History of Changes
Other Study ID Numbers: G20020584
First Posted: July 23, 2007    Key Record Dates
Last Update Posted: July 23, 2007
Last Verified: July 2007

Keywords provided by Zhejiang University:
Congenital Hypothyroidism
pregnancy
iodine
deficiency

Additional relevant MeSH terms:
Hypothyroidism
Congenital Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Genetic Diseases, Inborn