Iodine ReactionNCT03710148
The Effect of Iodine Intakes on Maternal and Infant Health and the Study of Iodine RNI for Different Stages of Pregnancy
An observational study of Iodine Reaction and Iodine Compounds Overdose, run by Wanqi Zhang at 3 sites in China.
Trial summary
This study determined the effects of different iodine intake on the maternal and infant health and provide evidence for studying the RNI and UL of iodine in pregnant women. 1. The study of effect on mothers and their infants of the lack of iodine at different gestation in adequate iodine area. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Reaction, Iodine Compounds Overdose, Pregnancy Related
- What is being tested?
- Natural exposure of deficient or excessive iodine
- How many people
- 2,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2014to 31 Dec 2020
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women were recruited at Tanggu Maternity Hospital and Maternal, Tianjin Child Health Care Service Center and the Maternal and Gaoqing Child Health Hospital, Shandong.
Who may be able to join
- 1) aged between 18-35 years old; 2) singleton pregnancy; 3) Living in Tianjin or Shandong at least 5 years; 4) no history of any thyroid diseases; 5) no medication or supplementation of iodine.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 2 recruiting
- Recruiting
Tanggu Maternity Hospital
Tianjin
Chongdan Wang, Master
Yanting Chen, BA
- Completed
Tianjin Maternal and Child Health Care Center
Tianjin
- Recruiting
Gaoqing Maternal and Child Health Care Center
Zibo, Shandong
Yuangui Cheng, BA
Wei Wang, BA
About this study
This study determined the effects of different iodine intake on the maternal and infant health and provide evidence for studying the RNI and UL of iodine in pregnant women.
- The study of effect on mothers and their infants of the lack of iodine at different gestation in adequate iodine area. The purpose of this study was to detect the maternal thyroid function, growth and neuropsychological development of infants in different pregnancy women with diverse iodine intake levels, and to make a clear evaluation for the influence of iodine deficiency during different pregnancy by following up iodine suitable early pregnancy women and mild iodine deficient three pregnancy women as well as their infants.
- The study of recommended iodine intake (RNI) for healthy pregnant women in three pregnancy. Different pregnancy women with different iodine intake levels were recruited and carried out iodine balance experiment in the case of not interfering with their diet. In addition, the iodine intake of the pregnant women when they reached "zero iodine balance" was calculated, that was EAR of iodine in pregnant women. In conclusion, the iodine balance experiment in pregnant women at different pregnancy improved the sample collection methods and evaluation criteria and was more scientific and reasonable than the classic iodine balance experiment.
- The study of effect of different levels of high iodine exposure on pregnant women, delivery women and their infants.
In this study, we made a prospective study of the early pregnancy women and their infants exposed to different high iodine levels in high water iodine areas. At first we defined the effects of long-term iodine excess exposure on the health of the mother and the infants by combining with the reference index of the normal value of the thyroid function in different maternal and postpartum periods, the level of growth and development of the offspring and the assessment of the level of neuropsychological development. Furthermore the harmful effects of different high levels of iodine exposure on pregnant women was synthetically analyzed. This study obtained the safe intake level of iodine for pregnant women and provided scientific basis for the formulation of iodine UL in pregnant women in China.
Read the detailed description
- The relationship between iodine deficiency during pregnancy and maternal offspring health
- Screening of pregnant women with iodine deficiency: A prevalence survey of pregnant women was conducted in iodine-sufficient area, combined with the results of single spot urinary concentration, 24h urinary iodine concentration and thyroglobulin level, screening out pregnant women with iodine deficiency during first, second and third trimester of pregnancy. There are 60 pregnant women in each group. At the same time, 60 pregnant women with iodine-sufficient during early pregnancy were selected, and the total number of the four groups is 240.
- Effects of iodine deficiency on pregnant women during different pregnancy: Pregnant women with iodine deficiency were gived nutritional guidance, and were advised to take iodine supplements. Follow-up with regularly collecting fasting venous blood, dried whole blood and single spot urine was conducted, in order to dynamically grasp the iodine nutritional status and thyroid function of pregnant women during different pregnancy, and clarify the influence of iodine deficiency on pregnant women in each group.
- Effects of iodine deficiency on offspring during different pregnancy: The offspring of follow-up pregnant women were observed, collecting the heel blood at birth for measuring TSH, and performing physical examination. Assessment of neuropsychological development in offspring for two years after delivery was performed , in order to clarify the effects of iodine deficiency on the neuropsychological development of offspring in each group.
- Statistical analysis:
Normally distributed variables were reported as the mean ± standard deviation, comparison between groups were analyzed with the use of t-test or analysis of variance (ANOVA), and Pearson linear correlation was used for correlation analysis; Urinary iodine level is lognormal distribution, so it was converted into logarithmic form and then analyzed. Non-normally distributed variables were presented as median and interquartile range. The Wilcoxon rank sum test was used for comparison between groups, and correlation analysis was performed using the Spearman rank correlation test. The chi-squared test was adopted for the comparison of enumeration data. P values below 0.05 was considered statistically significant.
- Study the RNI of iodine on pregnant women during different pregnancy:
- Screening of pregnant women during different pregnancy: A prevalence survey of pregnant women was conducted in iodine-sufficient area, based on 24h urinary iodine concentration, thyroglobulin level, related health check and medical history query results, screening out pregnant women who meet the requirements of this study during first, second and third trimester of pregnancy. Each group has 20 pregnant women, and the total number is 60.
- Reasearch of the iodine EAR of pregnant women during different pregnancy: Iodine balance studies were performed on healthy pregnant women during first, second and third trimester of pregnancy to evaluate the daily iodine intake and excretion, including collecting and testing 24h dietary iodine intake, 24h urinary iodine and fecal iodine excretion of subjects. The daily respiratory iodine intake and excretion of subjects was assessed by measuring the iodine content in the air and exhaled breath. In addition, according to the positive correlation between iodine balance value and iodine intake, a scatter plot was drawn and curve fitting was performed. According to the results of iodine balance experiment, the iodine balance regression curves of first, second and third trimester of pregnancy were established , in order to determine the level of iodine intake when the pregnant women reach the iodine balance, which is the estimated average requirement (EAR) of pregnant women during different pregnancy.
- Research of iodine RNI on pregnant women during different pregnancy:
Based on the obtained EAR values of iodine for different pregnancy and the 20% coefficient of variation (CV), according to the formula: RNI=EAR+2CV=1.4EAR, the iodine RNI values of pregnant women in different gestation were derived.
- Study on the relationship between iodine excess and maternal offspring health and iodine UL of pregnant women
- Prospective study: Pregnant women during early pregnancy who were exposed to different excessive water iodine intake were enrolled in a large-scale epidemiological prospective study, in order to assess the levels of iodine intake by collecting and testing random urinary iodine and 24h urinary iodine levels, and to detect the thyroid function indicators under different iodine intake levels to evaluate the health effects and harms of different high iodine intake on pregnant women. At the same time, the growth and development of the offspring and the level of neuropsychological development were evaluated to determine the long-term iodine excess exposure to the health of pregnant women and offspring.
- Discussion on iodine UL of pregnant women: According to the urinary iodine level during pregnancy, the subjects were divided into groups with different iodine intakes, with the TSH abnormal rate of pregnant women > 5% and the increase of FT3/FT4 as the end point, comprehensively determining the harmful effects of different iodine intake on pregnant women and offspring, analyzing the iodine safety intake level suitabled for pregnant women, and exploring the iodine UL of pregnant women.
- Statistical methods:
Epi-data was used to enter survey data. Univariate statistical analysis was used to analyze the differences in evaluation indicators between different iodine intake levels.. Multivariate statistical analysis methods were used to analyze the safety of each iodine intake level under multiple factors.
- Being tested
- Natural exposure of deficient or excessive iodine
- Keywords
- Iodine, Estimated Average Requirement, Recommended Nutritent Intake, Tolerable Upper Intake Level, Pregnant Women, Pregnancy, EAR, RNI, UL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural exposure of deficient or excessive iodineOther
Natural exposure of deficient iodine from diet \& drinking water, and of excessive iodine intake from drinking water
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid goiter confirmed by ultrasonographic thyroid volume
Thyroid lobe volume was calculated according to the following formula: V (mL)=0.479×d×w×l (mm)/1000, and TV was records as the sum of both lobes.
Measured: 3 years
Thyroid dysfunction confirmed by serum concentrations of FT3, FT4, TSH ,TPOAB and TGAb
Thyroid function is not in the normal reference range and is defined as thyroid dysfunction
Measured: 3 years
Evaluation of neuropsychological development of children at age 2
Children were tested by the neurodevelopmental scale compiled by the Capital Institute of Pediatrics.In this experiment, DQ (> 130) was classified as excellent, 115-129 as upper, 85-114 as middle, 70-84 as lower, and (< 69) as mental retardation.
Measured: 2 years
Iodine intake were measured by Iodine balance experiment
24h iodine intake =24h dietary iodine intake + 24h water iodine intake + 24h respiratory iodine intake
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Jan 2014
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Iodine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wanqi Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Institute for Endemic Disease Control and Research, Tianjin Maternal and Child Health Care Center
- Responsible party
- Sponsor-investigator, Wanqi Zhang, Tianjin Medical University
- Investigators
- Ping Shao, Master, Principal investigator, Tianjin Maternal and Child Health Care CenterXiaoming Wang, Master, Principal investigator, Shandong Institute for Endemic Disease Control and ResearchLaixing Lin, Master, Principal investigator, Tianjin Medical University Metabolic Diseases HospitalJun Shen, Master, Principal investigator, Tianjin Medical UniversityLong Tan, PhD, Principal investigator, Tianjin Medical UniversityWen Chen, PhD, Principal investigator, Tianjin Medical UniversityWei Wang, BA, Principal investigator, Tianjin Medical UniversityTingkai Cui, BA, Principal investigator, Tianjin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710148
- Sponsor's protocol ID
- NSFC-81330064
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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 22205314Boyages SC. Clinical review 49: Iodine deficiency disorders. J Clin Endocrinol Metab. 1993 Sep;77(3):587-91. doi: 10.1210/jcem.77.3.8370679. No abstract available.
PubMed 8370679Zimmermann 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 22892867Caldwell KL, Makhmudov A, Ely E, Jones RL, Wang RY. Iodine status of the U.S. population, National Health and Nutrition Examination Survey, 2005-2006 and 2007-2008. Thyroid. 2011 Apr;21(4):419-27. doi: 10.1089/thy.2010.0077.
PubMed 21323596Hollowell JG, Haddow JE. The prevalence of iodine deficiency in women of reproductive age in the United States of America. Public Health Nutr. 2007 Dec;10(12A):1532-9; discussion 1540-1. doi: 10.1017/S1368980007360862.
PubMed 18053275Fuse Y, Ohashi T, Yamaguchi S, Yamaguchi M, Shishiba Y, Irie M. Iodine status of pregnant and postpartum Japanese women: effect of iodine intake on maternal and neonatal thyroid function in an iodine-sufficient area. J Clin Endocrinol Metab. 2011 Dec;96(12):3846-54. doi: 10.1210/jc.2011-2180. Epub 2011 Sep 28.
PubMed 21956426Vandevijvere S, Amsalkhir S, Mourri AB, Van Oyen H, Moreno-Reyes R. Iodine deficiency among Belgian pregnant women not fully corrected by iodine-containing multivitamins: a national cross-sectional survey. Br J Nutr. 2013 Jun 28;109(12):2276-84. doi: 10.1017/S0007114512004473. Epub 2012 Oct 19.
PubMed 23084115Zou S, Wu F, Guo C, Song J, Huang C, Zhu Z, Yu H, Guo Y, Lu X, Ruan Y. Iodine nutrition and the prevalence of thyroid disease after salt iodization: a cross-sectional survey in Shanghai, a coastal area in China. PLoS One. 2012;7(7):e40718. doi: 10.1371/journal.pone.0040718. Epub 2012 Jul 27.
PubMed 22911705Swanson CA, Zimmermann MB, Skeaff S, Pearce EN, Dwyer JT, Trumbo PR, Zehaluk C, Andrews KW, Carriquiry A, Caldwell KL, Egan SK, Long SE, Bailey RL, Sullivan KM, Holden JM, Betz JM, Phinney KW, Brooks SP, Johnson CL, Haggans CJ. Summary of an NIH workshop to identify research needs to improve the monitoring of iodine status in the United States and to inform the DRI. J Nutr. 2012 Jun;142(6):1175S-85S. doi: 10.3945/jn.111.156448. Epub 2012 May 2.
PubMed 22551802Zimmermann M, Delange F. Iodine supplementation of pregnant women in Europe: a review and recommendations. Eur J Clin Nutr. 2004 Jul;58(7):979-84. doi: 10.1038/sj.ejcn.1601933.
PubMed 15220938Brucker-Davis F, Ferrari P, Gal J, Berthier F, Fenichel P, Hieronimus S. Iodine status has no impact on thyroid function in early healthy pregnancy. J Thyroid Res. 2012;2012:168764. doi: 10.1155/2012/168764. Epub 2012 Nov 28.
PubMed 23251828Zimmermann MB. The adverse effects of mild-to-moderate iodine deficiency during pregnancy and childhood: a review. Thyroid. 2007 Sep;17(9):829-35. doi: 10.1089/thy.2007.0108.
PubMed 17956157Delange F. Iodine requirements during pregnancy, lactation and the neonatal period and indicators of optimal iodine nutrition. Public Health Nutr. 2007 Dec;10(12A):1571-80; discussion 1581-3. doi: 10.1017/S1368980007360941.
PubMed 18053281Burns R, O'Herlihy C, Smyth PP. The placenta as a compensatory iodine storage organ. Thyroid. 2011 May;21(5):541-6. doi: 10.1089/thy.2010.0203. Epub 2011 Mar 21.
PubMed 21417918Lazarus JH. Thyroid function in pregnancy. Br Med Bull. 2011;97:137-48. doi: 10.1093/bmb/ldq039. Epub 2010 Dec 23.
PubMed 21186204
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iodine Intakes on Maternal and Infant Health and the Study of Iodine RNI for Different Stages of Pregnancy
- ClinicalTrials.gov ID
- NCT03710148
- Acronym / sponsor ID
- NSFC-81330064
- Keywords
- Iodine, Estimated Average Requirement, Recommended Nutritent Intake, Tolerable Upper Intake Level, Pregnant Women, Pregnancy, EAR, RNI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Wanqi ZhangUniversity, hospital or other
- Collaborators
- Shandong Institute for Endemic Disease Control and Research, Tianjin Maternal and Child Health Care Center
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study determined the effects of different iodine intake on the maternal and infant health and provide evidence for studying the RNI and UL of iodine in pregnant women.
- The study of effect on mothers and their infants of the lack of iodine at different gestation in adequate iodine area. The purpose of this study was to detect the maternal thyroid function, growth and neuropsychological development of infants in different pregnancy women with diverse iodine intake levels, and to make a clear evaluation for the influence of iodine deficiency during different pregnancy by following up iodine suitable early pregnancy women and mild iodine deficient three pregnancy women as well as their infants.
- The study of recommended iodine intake (RNI) for healthy pregnant women in three pregnancy. Different pregnancy women with different iodine intake levels were recruited and carried out iodine balance experiment in the case of not interfering with their diet. In addition, the iodine intake of the pregnant women when they reached "zero iodine balance" was calculated, that was EAR of iodine in pregnant women. In conclusion, the iodine balance experiment in pregnant women at different pregnancy improved the sample collection methods and evaluation criteria and was more scientific and reasonable than the classic iodine balance experiment.
- The study of effect of different levels of high iodine exposure on pregnant women, delivery women and their infants.
In this study, we made a prospective study of the early pregnancy women and their infants exposed to different high iodine levels in high water iodine areas. At first we defined the effects of long-term iodine excess exposure on the health of the mother and the infants by combining with the reference index of the normal value of the thyroid function in different maternal and postpartum periods, the level of growth and development of the offspring and the assessment of the level of neuropsychological development. Furthermore the harmful effects of different high levels of iodine exposure on pregnant women was synthetically analyzed. This study obtained the safe intake level of iodine for pregnant women and provided scientific basis for the formulation of iodine UL in pregnant women in China.
Detailed description
- The relationship between iodine deficiency during pregnancy and maternal offspring health
- Screening of pregnant women with iodine deficiency: A prevalence survey of pregnant women was conducted in iodine-sufficient area, combined with the results of single spot urinary concentration, 24h urinary iodine concentration and thyroglobulin level, screening out pregnant women with iodine deficiency during first, second and third trimester of pregnancy. There are 60 pregnant women in each group. At the same time, 60 pregnant women with iodine-sufficient during early pregnancy were selected, and the total number of the four groups is 240.
- Effects of iodine deficiency on pregnant women during different pregnancy: Pregnant women with iodine deficiency were gived nutritional guidance, and were advised to take iodine supplements. Follow-up with regularly collecting fasting venous blood, dried whole blood and single spot urine was conducted, in order to dynamically grasp the iodine nutritional status and thyroid function of pregnant women during different pregnancy, and clarify the influence of iodine deficiency on pregnant women in each group.
- Effects of iodine deficiency on offspring during different pregnancy: The offspring of follow-up pregnant women were observed, collecting the heel blood at birth for measuring TSH, and performing physical examination. Assessment of neuropsychological development in offspring for two years after delivery was performed , in order to clarify the effects of iodine deficiency on the neuropsychological development of offspring in each group.
- Statistical analysis:
Normally distributed variables were reported as the mean ± standard deviation, comparison between groups were analyzed with the use of t-test or analysis of variance (ANOVA), and Pearson linear correlation was used for correlation analysis; Urinary iodine level is lognormal distribution, so it was converted into logarithmic form and then analyzed. Non-normally distributed variables were presented as median and interquartile range. The Wilcoxon rank sum test was used for comparison between groups, and correlation analysis was performed using the Spearman rank correlation test. The chi-squared test was adopted for the comparison of enumeration data. P values below 0.05 was considered statistically significant.
- Study the RNI of iodine on pregnant women during different pregnancy:
- Screening of pregnant women during different pregnancy: A prevalence survey of pregnant women was conducted in iodine-sufficient area, based on 24h urinary iodine concentration, thyroglobulin level, related health check and medical history query results, screening out pregnant women who meet the requirements of this study during first, second and third trimester of pregnancy. Each group has 20 pregnant women, and the total number is 60.
- Reasearch of the iodine EAR of pregnant women during different pregnancy: Iodine balance studies were performed on healthy pregnant women during first, second and third trimester of pregnancy to evaluate the daily iodine intake and excretion, including collecting and testing 24h dietary iodine intake, 24h urinary iodine and fecal iodine excretion of subjects. The daily respiratory iodine intake and excretion of subjects was assessed by measuring the iodine content in the air and exhaled breath. In addition, according to the positive correlation between iodine balance value and iodine intake, a scatter plot was drawn and curve fitting was performed. According to the results of iodine balance experiment, the iodine balance regression curves of first, second and third trimester of pregnancy were established , in order to determine the level of iodine intake when the pregnant women reach the iodine balance, which is the estimated average requirement (EAR) of pregnant women during different pregnancy.
- Research of iodine RNI on pregnant women during different pregnancy:
Based on the obtained EAR values of iodine for different pregnancy and the 20% coefficient of variation (CV), according to the formula: RNI=EAR+2CV=1.4EAR, the iodine RNI values of pregnant women in different gestation were derived.
- Study on the relationship between iodine excess and maternal offspring health and iodine UL of pregnant women
- Prospective study: Pregnant women during early pregnancy who were exposed to different excessive water iodine intake were enrolled in a large-scale epidemiological prospective study, in order to assess the levels of iodine intake by collecting and testing random urinary iodine and 24h urinary iodine levels, and to detect the thyroid function indicators under different iodine intake levels to evaluate the health effects and harms of different high iodine intake on pregnant women. At the same time, the growth and development of the offspring and the level of neuropsychological development were evaluated to determine the long-term iodine excess exposure to the health of pregnant women and offspring.
- Discussion on iodine UL of pregnant women: According to the urinary iodine level during pregnancy, the subjects were divided into groups with different iodine intakes, with the TSH abnormal rate of pregnant women > 5% and the increase of FT3/FT4 as the end point, comprehensively determining the harmful effects of different iodine intake on pregnant women and offspring, analyzing the iodine safety intake level suitabled for pregnant women, and exploring the iodine UL of pregnant women.
- Statistical methods:
Epi-data was used to enter survey data. Univariate statistical analysis was used to analyze the differences in evaluation indicators between different iodine intake levels.. Multivariate statistical analysis methods were used to analyze the safety of each iodine intake level under multiple factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women were recruited at Tanggu Maternity Hospital and Maternal, Tianjin Child Health Care Service Center and the Maternal and Gaoqing Child Health Hospital, Shandong.
Key inclusion criteria (1 listed)
- 1) aged between 18-35 years old; 2) singleton pregnancy; 3) Living in Tianjin or Shandong at least 5 years; 4) no history of any thyroid diseases; 5) no medication or supplementation of iodine.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural exposure of deficient or excessive iodineNatural exposure of deficient iodine from diet \& drinking water, and of excessive iodine intake from drinking water | Other | – |
Primary outcome
Thyroid goiter confirmed by ultrasonographic thyroid volume
Time frame: 3 years
Thyroid lobe volume was calculated according to the following formula: V (mL)=0.479×d×w×l (mm)/1000, and TV was records as the sum of both lobes.
Thyroid dysfunction confirmed by serum concentrations of FT3, FT4, TSH ,TPOAB and TGAb
Time frame: 3 years
Thyroid function is not in the normal reference range and is defined as thyroid dysfunction
Evaluation of neuropsychological development of children at age 2
Time frame: 2 years
Children were tested by the neurodevelopmental scale compiled by the Capital Institute of Pediatrics.In this experiment, DQ (> 130) was classified as excellent, 115-129 as upper, 85-114 as middle, 70-84 as lower, and (< 69) as mental retardation.
Iodine intake were measured by Iodine balance experiment
Time frame: 1 years
24h iodine intake =24h dietary iodine intake + 24h water iodine intake + 24h respiratory iodine intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Background: PubMed 22205314Sang 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.
- Background: PubMed 8370679Boyages SC. Clinical review 49: Iodine deficiency disorders. J Clin Endocrinol Metab. 1993 Sep;77(3):587-91. doi: 10.1210/jcem.77.3.8370679. No abstract available.
- Background: PubMed 22892867Zimmermann MB, Andersson M. Update on iodine status worldwide. Curr Opin Endocrinol Diabetes Obes. 2012 Oct;19(5):382-7. doi: 10.1097/MED.0b013e328357271a.
- Background: PubMed 21323596Caldwell KL, Makhmudov A, Ely E, Jones RL, Wang RY. Iodine status of the U.S. population, National Health and Nutrition Examination Survey, 2005-2006 and 2007-2008. Thyroid. 2011 Apr;21(4):419-27. doi: 10.1089/thy.2010.0077.
- Background: PubMed 18053275Hollowell JG, Haddow JE. The prevalence of iodine deficiency in women of reproductive age in the United States of America. Public Health Nutr. 2007 Dec;10(12A):1532-9; discussion 1540-1. doi: 10.1017/S1368980007360862.
- Background: PubMed 21956426Fuse Y, Ohashi T, Yamaguchi S, Yamaguchi M, Shishiba Y, Irie M. Iodine status of pregnant and postpartum Japanese women: effect of iodine intake on maternal and neonatal thyroid function in an iodine-sufficient area. J Clin Endocrinol Metab. 2011 Dec;96(12):3846-54. doi: 10.1210/jc.2011-2180. Epub 2011 Sep 28.
- Background: PubMed 23084115Vandevijvere S, Amsalkhir S, Mourri AB, Van Oyen H, Moreno-Reyes R. Iodine deficiency among Belgian pregnant women not fully corrected by iodine-containing multivitamins: a national cross-sectional survey. Br J Nutr. 2013 Jun 28;109(12):2276-84. doi: 10.1017/S0007114512004473. Epub 2012 Oct 19.
- Background: PubMed 22911705Zou S, Wu F, Guo C, Song J, Huang C, Zhu Z, Yu H, Guo Y, Lu X, Ruan Y. Iodine nutrition and the prevalence of thyroid disease after salt iodization: a cross-sectional survey in Shanghai, a coastal area in China. PLoS One. 2012;7(7):e40718. doi: 10.1371/journal.pone.0040718. Epub 2012 Jul 27.
- Background: PubMed 22551802Swanson CA, Zimmermann MB, Skeaff S, Pearce EN, Dwyer JT, Trumbo PR, Zehaluk C, Andrews KW, Carriquiry A, Caldwell KL, Egan SK, Long SE, Bailey RL, Sullivan KM, Holden JM, Betz JM, Phinney KW, Brooks SP, Johnson CL, Haggans CJ. Summary of an NIH workshop to identify research needs to improve the monitoring of iodine status in the United States and to inform the DRI. J Nutr. 2012 Jun;142(6):1175S-85S. doi: 10.3945/jn.111.156448. Epub 2012 May 2.
- Background: PubMed 15220938Zimmermann M, Delange F. Iodine supplementation of pregnant women in Europe: a review and recommendations. Eur J Clin Nutr. 2004 Jul;58(7):979-84. doi: 10.1038/sj.ejcn.1601933.
- Background: PubMed 23251828Brucker-Davis F, Ferrari P, Gal J, Berthier F, Fenichel P, Hieronimus S. Iodine status has no impact on thyroid function in early healthy pregnancy. J Thyroid Res. 2012;2012:168764. doi: 10.1155/2012/168764. Epub 2012 Nov 28.
- Background: PubMed 17956157Zimmermann MB. The adverse effects of mild-to-moderate iodine deficiency during pregnancy and childhood: a review. Thyroid. 2007 Sep;17(9):829-35. doi: 10.1089/thy.2007.0108.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Shao, Master principal investigator
Tianjin Maternal and Child Health Care Center
Xiaoming Wang, Master principal investigator
Shandong Institute for Endemic Disease Control and Research
Laixing Lin, Master principal investigator
Tianjin Medical University Metabolic Diseases Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Reaction and Iodine Compounds Overdose, run by Wanqi Zhang at 3 sites 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 0 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wanqi Zhang, PhD ((86) 22 83336595, wqzhang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid goiter confirmed by ultrasonographic thyroid volume (time frame: 3 years). The study lists 4 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 NCT03710148, which also lists 33 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 18 Oct 2018.