Iodine Status in Pregnant Women and Their Newborns: is Congenital Hypothyroidism Related to Iodine Deficiency in Pregnancy?
Recruitment status was Recruiting
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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 Time Perspective: Prospective |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2010 |
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 |
Inclusion Criteria:
- Pregnant women in Zhejiang province (and their newborns)
Exclusion Criteria:
- Endocrine disease
Contacts and Locations| Contact: Zhengyan Zhao, M.D. | 008657187061007 | zhaozy@zju.edu.cn |
| 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. | |
| 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:
|
Congenital Hypothyroidism Hypothyroidism Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Genetic Diseases, Inborn Endocrine System Diseases Thyroid Diseases |
Iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013