Iodine Nutrition During Pregnancy and Related Neonatal Physical Development

NCT02586220 | Completed DMC

• 1 other identifier: XHEC-C-2015-003-2
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy; Iodine Deficiency

Outcome Measures

Primary Outcomes (1)

• urinary iodine (UI) concentrations

  up to three months

Secondary Outcomes (2)

• thyroid stimulating hormone level of newborns

  up to three months

• daily iodine intake of pregnant women

  up to three months

Study Arms (2)

normal pregnant women

150 normal pregnant women (28-32 weeks' gestation)

pregnant women with gestational

100 pregnant women with gestational diabetes (28-32 weeks' gestation)

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

250 pregnant women recruited from antenatal outpatient clinics in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, China.

You may qualify if:

• years,
• weeks' gestation,

You may not qualify if:

• a known history of thyroid disease in the non-pregnant state and previous.

Sponsors & Collaborators

• qingya tang: lead

Study Sites (2)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine

Shanghai, Shanghai Municipality, 200092, China

Location

Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (30)

• 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.

  PMID: 25050783 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.

  PMID: 21918061 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.

  PMID: 10770167 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.

  PMID: 16391581 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.

  PMID: 10745289 BACKGROUND

• Zimmermann MB. Iodine deficiency. Endocr Rev. 2009 Jun;30(4):376-408. doi: 10.1210/er.2009-0011. Epub 2009 May 21.

  PMID: 19460960 BACKGROUND

• 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.

  PMID: 19556382 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.

  PMID: 11584093 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.

  PMID: 16803441 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.

  PMID: 24342882 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.

  PMID: 23186967 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.

  PMID: 18053287 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.

  PMID: 21323596 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.

  PMID: 20554903 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.

  PMID: 23157653 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.

  PMID: 24398008 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.

  PMID: 22911705 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.

  PMID: 24282581 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.

  PMID: 19114540 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.

  PMID: 25031330 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.

  PMID: 22381147 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.

  PMID: 24025628 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.

  PMID: 23548753 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.

  PMID: 4312017 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.

  PMID: 4350937 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.

  PMID: 3032814 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.

  PMID: 19567536 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.

  PMID: 19348584 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.

  PMID: 23633204 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.

  PMID: 23706508 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

spot urine sample of pregnant women

Study Officials

• Qingya Tang, MMed

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: October 26, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)