Iodine Nutrition During Pregnancy and Related Neonatal Physical Development
NCT ID: NCT02586220
Last Updated: 2020-03-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
250 participants
Study Classification
OBSERVATIONAL
Study Start Date
2015-08-31
Study Completion Date
2016-07-31
Brief Summary
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Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.
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Detailed Description
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Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.
Design: prospective cohort study
Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.
Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.
Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.
Design: prospective cohort study
Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.
Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.
Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.
Conditions
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Pregnancy
Iodine Deficiency
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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normal pregnant women
150 normal pregnant women (28-32 weeks' gestation)
No interventions assigned to this group
pregnant women with gestational
100 pregnant women with gestational diabetes (28-32 weeks' gestation)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 22-35 years,
* 28-32 weeks' gestation,
* 28-32 weeks' gestation,
Exclusion Criteria
* a known history of thyroid disease in the non-pregnant state and previous.
Minimum Eligible Age
22 Years
Maximum Eligible Age
35 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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qingya tang
OTHER
Sponsor Role
lead
Responsible Party
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qingya tang
Chief Physician
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Qingya Tang, MMed
Role: PRINCIPAL_INVESTIGATOR
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine
Shanghai, Shanghai Municipality, China
Site Status
Xinhua Hospital
Shanghai, Shanghai Municipality, China
Site Status
Countries
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China
References
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Luo Y, Kawashima A, Ishido Y, Yoshihara A, Oda K, Hiroi N, Ito T, Ishii N, Suzuki K. Iodine excess as an environmental risk factor for autoimmune thyroid disease. Int J Mol Sci. 2014 Jul 21;15(7):12895-912. doi: 10.3390/ijms150712895.
Reference Type
BACKGROUND
Konig F, Andersson M, Hotz K, Aeberli I, Zimmermann MB. Ten repeat collections for urinary iodine from spot samples or 24-hour samples are needed to reliably estimate individual iodine status in women. J Nutr. 2011 Nov;141(11):2049-54. doi: 10.3945/jn.111.144071. Epub 2011 Sep 14.
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BACKGROUND
Als C, Helbling A, Peter K, Haldimann M, Zimmerli B, Gerber H. Urinary iodine concentration follows a circadian rhythm: a study with 3023 spot urine samples in adults and children. J Clin Endocrinol Metab. 2000 Apr;85(4):1367-9. doi: 10.1210/jcem.85.4.6496.
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BACKGROUND
Busnardo B, Nacamulli D, Zambonin L, Mian C, Piccolo M, Girelli ME. Restricted intraindividual urinary iodine concentration variability in nonfasting subjects. Eur J Clin Nutr. 2006 Mar;60(3):421-5. doi: 10.1038/sj.ejcn.1602334.
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BACKGROUND
Knudsen N, Christiansen E, Brandt-Christensen M, Nygaard B, Perrild H. Age- and sex-adjusted iodine/creatinine ratio. A new standard in epidemiological surveys? Evaluation of three different estimates of iodine excretion based on casual urine samples and comparison to 24 h values. Eur J Clin Nutr. 2000 Apr;54(4):361-3. doi: 10.1038/sj.ejcn.1600935.
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Zimmermann MB. Iodine deficiency. Endocr Rev. 2009 Jun;30(4):376-408. doi: 10.1210/er.2009-0011. Epub 2009 May 21.
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Vejbjerg P, Knudsen N, Perrild H, Laurberg P, Carle A, Pedersen IB, Rasmussen LB, Ovesen L, Jorgensen T. Thyroglobulin as a marker of iodine nutrition status in the general population. Eur J Endocrinol. 2009 Sep;161(3):475-81. doi: 10.1530/EJE-09-0262. Epub 2009 Jun 25.
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BACKGROUND
van den Briel T, West CE, Hautvast JG, Vulsma T, de Vijlder JJ, Ategbo EA. Serum thyroglobulin and urinary iodine concentration are the most appropriate indicators of iodine status and thyroid function under conditions of increasing iodine supply in schoolchildren in Benin. J Nutr. 2001 Oct;131(10):2701-6. doi: 10.1093/jn/131.10.2701.
Reference Type
BACKGROUND
Travers CA, Guttikonda K, Norton CA, Lewis PR, Mollart LJ, Wiley V, Wilcken B, Eastman CJ, Boyages SC. Iodine status in pregnant women and their newborns: are our babies at risk of iodine deficiency? Med J Aust. 2006 Jun 19;184(12):617-20. doi: 10.5694/j.1326-5377.2006.tb00417.x.
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BACKGROUND
Leung AM, Braverman LE. Consequences of excess iodine. Nat Rev Endocrinol. 2014 Mar;10(3):136-42. doi: 10.1038/nrendo.2013.251. Epub 2013 Dec 17.
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BACKGROUND
Katz PM, Leung AM, Braverman LE, Pearce EN, Tomlinson G, He X, Vertes J, Okun N, Walfish PG, Feig DS. Iodine nutrition during pregnancy in Toronto, Canada. Endocr Pract. 2013 Mar-Apr;19(2):206-11. doi: 10.4158/EP12193.OR.
Reference Type
BACKGROUND
WHO Secretariat; Andersson M, de Benoist B, Delange F, Zupan J. Prevention and control of iodine deficiency in pregnant and lactating women and in children less than 2-years-old: conclusions and recommendations of the Technical Consultation. Public Health Nutr. 2007 Dec;10(12A):1606-11. doi: 10.1017/S1368980007361004. No abstract available.
Reference Type
BACKGROUND
Caldwell 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.
Reference Type
BACKGROUND
Perrine CG, Herrick K, Serdula MK, Sullivan KM. Some subgroups of reproductive age women in the United States may be at risk for iodine deficiency. J Nutr. 2010 Aug;140(8):1489-94. doi: 10.3945/jn.109.120147. Epub 2010 Jun 16.
Reference Type
BACKGROUND
Sullivan KM, Perrine CG, Pearce EN, Caldwell KL. Monitoring the iodine status of pregnant women in the United States. Thyroid. 2013 Apr;23(4):520-1. doi: 10.1089/thy.2012.0217. No abstract available.
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BACKGROUND
Bath SC, Walter A, Taylor A, Wright J, Rayman MP. Iodine deficiency in pregnant women living in the South East of the UK: the influence of diet and nutritional supplements on iodine status. Br J Nutr. 2014 May;111(9):1622-31. doi: 10.1017/S0007114513004030. Epub 2014 Jan 7.
Reference Type
BACKGROUND
Zou 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.
Reference Type
BACKGROUND
Meng F, Zhao R, Liu P, Liu L, Liu S. Assessment of iodine status in children, adults, pregnant women and lactating women in iodine-replete areas of China. PLoS One. 2013 Nov 25;8(11):e81294. doi: 10.1371/journal.pone.0081294. eCollection 2013.
Reference Type
BACKGROUND
Alvarez-Pedrerol M, Guxens M, Mendez M, Canet Y, Martorell R, Espada M, Plana E, Rebagliato M, Sunyer J. Iodine levels and thyroid hormones in healthy pregnant women and birth weight of their offspring. Eur J Endocrinol. 2009 Mar;160(3):423-9. doi: 10.1530/EJE-08-0716. Epub 2008 Dec 29.
Reference Type
BACKGROUND
Rydbeck F, Rahman A, Grander M, Ekstrom EC, Vahter M, Kippler M. Maternal urinary iodine concentration up to 1.0 mg/L is positively associated with birth weight, length, and head circumference of male offspring. J Nutr. 2014 Sep;144(9):1438-44. doi: 10.3945/jn.114.193029. Epub 2014 Jul 16.
Reference Type
BACKGROUND
Olivares JL, Olivi GI, Verdasco C, Ortiz VA, Mayer MA, Cresto JC. Low iodine intake during pregnancy: relationship to placental development and head circumference in newborn. Endocrinol Nutr. 2012 May;59(5):326-30. doi: 10.1016/j.endonu.2011.12.005. Epub 2012 Feb 29.
Reference Type
BACKGROUND
Zhou SJ, Anderson AJ, Gibson RA, Makrides M. Effect of iodine supplementation in pregnancy on child development and other clinical outcomes: a systematic review of randomized controlled trials. Am J Clin Nutr. 2013 Nov;98(5):1241-54. doi: 10.3945/ajcn.113.065854. Epub 2013 Sep 11.
Reference Type
BACKGROUND
Rebagliato M, Murcia M, Alvarez-Pedrerol M, Espada M, Fernandez-Somoano A, Lertxundi N, Navarrete-Munoz EM, Forns J, Aranbarri A, Llop S, Julvez J, Tardon A, Ballester F. Iodine supplementation during pregnancy and infant neuropsychological development. INMA Mother and Child Cohort Study. Am J Epidemiol. 2013 May 1;177(9):944-53. doi: 10.1093/aje/kws333. Epub 2013 Apr 1.
Reference Type
BACKGROUND
Kevany J, Fierro-Benitez R, Pretell EA, Stanbury JB. Prophylaxis and treatment of endemic goiter with iodized oil in rural Ecuador and Peru. Am J Clin Nutr. 1969 Dec;22(12):1597-607. doi: 10.1093/ajcn/22.12.1597.
Reference Type
BACKGROUND
Pretell EA, Torres T, Zenteno V, Cornejo M. Prophylaxis of endemic goiter with iodized oil in rural Peru. Adv Exp Med Biol. 1972;30:246-65. No abstract available.
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BACKGROUND
Pharoah PO, Connolly KJ. A controlled trial of iodinated oil for the prevention of endemic cretinism: a long-term follow-up. Int J Epidemiol. 1987 Mar;16(1):68-73. doi: 10.1093/ije/16.1.68.
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BACKGROUND
Velasco I, Carreira M, Santiago P, Muela JA, Garcia-Fuentes E, Sanchez-Munoz B, Garriga MJ, Gonzalez-Fernandez MC, Rodriguez A, Caballero FF, Machado A, Gonzalez-Romero S, Anarte MT, Soriguer F. Effect of iodine prophylaxis during pregnancy on neurocognitive development of children during the first two years of life. J Clin Endocrinol Metab. 2009 Sep;94(9):3234-41. doi: 10.1210/jc.2008-2652. Epub 2009 Jun 30.
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BACKGROUND
Berbel P, Mestre JL, Santamaria A, Palazon I, Franco A, Graells M, Gonzalez-Torga A, de Escobar GM. Delayed neurobehavioral development in children born to pregnant women with mild hypothyroxinemia during the first month of gestation: the importance of early iodine supplementation. Thyroid. 2009 May;19(5):511-9. doi: 10.1089/thy.2008.0341.
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BACKGROUND
Hynes KL, Otahal P, Hay I, Burgess JR. Mild iodine deficiency during pregnancy is associated with reduced educational outcomes in the offspring: 9-year follow-up of the gestational iodine cohort. J Clin Endocrinol Metab. 2013 May;98(5):1954-62. doi: 10.1210/jc.2012-4249. Epub 2013 Apr 30.
Reference Type
BACKGROUND
Bath SC, Steer CD, Golding J, Emmett P, Rayman MP. Effect of inadequate iodine status in UK pregnant women on cognitive outcomes in their children: results from the Avon Longitudinal Study of Parents and Children (ALSPAC). Lancet. 2013 Jul 27;382(9889):331-7. doi: 10.1016/S0140-6736(13)60436-5. Epub 2013 May 22.
Reference Type
BACKGROUND
Other Identifiers
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XHEC-C-2015-003-2
Identifier Type: -
Identifier Source: org_study_id
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