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Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?
This study is currently recruiting participants.
Verified by Zhejiang University, July 2007
Sponsored by: Zhejiang University
Information provided by: Zhejiang University
ClinicalTrials.gov Identifier: NCT00505479
  Purpose

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
Congenital Hypothyroidism
Pregnancy
Iodine Deficiency

Genetics Home Reference related topics: congenital hypothyroidism pseudoachondroplasia
Drug Information available for: Iodine Cadexomer iodine
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Longitudinal, Random Sample, Prospective Study

Further study details as provided by Zhejiang University:

Study Start Date: May 2007
Estimated Study Completion Date: May 2010
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in Zhejiang province (and their newborns)

Exclusion Criteria:

  • Endocrine disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Study ID Numbers: G20020584
Study First Received: July 20, 2007
Last Updated: July 20, 2007
ClinicalTrials.gov Identifier: NCT00505479  
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang University:
Congenital Hypothyroidism
pregnancy
iodine
deficiency

Study placed in the following topic categories:
Dwarfism
Bone Diseases, Endocrine
Cretinism
Endocrine System Diseases
Bone Diseases
Congenital hypothyroidism
Musculoskeletal Diseases
Genetic Diseases, Inborn
Congenital Hypothyroidism
Bone Diseases, Developmental
Iodine
Hypothyroidism
Endocrinopathy
Thyroid Diseases

ClinicalTrials.gov processed this record on January 16, 2009