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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT00505479
First received: July 20, 2007
Last updated: NA
Last verified: July 2007
History: No changes posted
  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

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on September 30, 2014