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Role of iodine-cont...
Role of iodine-containing multivitamins during pregnancy for children's brain function: protocol of an ongoing randomised controlled trial: the SWIDDICH study.
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- Manousou, Sofia, 1979 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sweden; Kungälvs Hosp, Sweden
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- Johansson, Birgitta, 1957 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology,Univ Gothenburg, Sweden
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- Chmielewska, Anna (author)
- Umeå universitet,Pediatrik,Department of Pediatrics, Medical University of Warsaw, Warsaw, Poland,Umea Univ, Sweden; Med Univ Warsaw, Poland
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- Eriksson, Janna, 1992 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sweden
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- Gutefeldt, Kerstin, 1972- (author)
- Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Endokrinmedicinska kliniken
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- Törnhage, Carl-Johan (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för pediatrik,Institute of Clinical Sciences, Department of Pediatrics,Skaraborg Hosp, Sweden; Univ Gothenburg, Sweden
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- Eggertsen, Robert, 1948 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för samhällsmedicin och folkhälsa,Institute of Medicine, School of Public Health and Community Medicine,Univ Gothenburg, Sweden; Molnlycke Hlth Care Ctr, Sweden
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- Malmgren, Helge, 1945 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sweden
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- Hulthén, Lena, 1947 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition,Univ Gothenburg, Sweden
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- Domellöf, Magnus, 1963- (author)
- Umeå universitet,Pediatrik,Umea Univ, Sweden
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- Nyström, Helena Filipsson, 1966 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine,Univ Gothenburg, Sweden; Sahlgrens Univ Hosp, Sweden
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(creator_code:org_t)
- BMJ Publishing Group Ltd, 2018
- 2018
- English.
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In: BMJ open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 8:4
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Abstract
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- Iodine is essential for normal brain development. Moderate and severe fetal iodine deficiency results in substantial to serious developmental delay in children. Mild iodine deficiency in pregnancy is associated with neurodevelopmental deficits in the offspring, but evidence from randomised trials is lacking. The aim of the Swedish Iodine in Pregnancy and Development in Children study is to determine the effect of daily supplementation with 150µg iodine during pregnancy on the offspring's neuropsychological development up to 14 years of age.Thyroid healthy pregnant women (n=1275: age range 18-40 years) at ≤12 weeks gestation will be randomly assigned to receive multivitamin supplements containing 150µg iodine or non-iodine-containing multivitamin daily throughout pregnancy. As a primary outcome, IQ will be measured in the offspring at 7 years (Wechsler Intelligence Scale for Children-V). As secondary outcomes, IQ will be measured at 3.5 and 14 years, psychomotor development at 18 months and 7 years, and behaviour at 3.5, 7 and 14 years. Iodine status (urinary iodine concentration) will be measured during pregnancy and in the offspring at 3.5, 7 and 14 years. Thyroid function (thyroid hormones, thyroglobulin), and deiodinase type 2 polymorphisms will be measured during pregnancy and in the offspring at 7 and 14 years. Structural MRI or other relevant structural or functional brain imaging procedures will be performed in a subgroup of children at 7 and 14 years. Background and socioeconomic information will be collected at all follow-up times.This study is approved by the Ethics Committee in Göteborg, Sweden (Diary numbers: 431-12 approved 18 June 2012 (pregnancy part) and 1089-16 approved 8 February 2017 (children follow-up)). According to Swedish regulations, dietary supplements are governed by the National Food Agency and not by the Medical Product Agency. Therefore, there is no requirement for a monitoring committee and the National Food Agency does not perform any audits of trial conduct. The trial will be conducted in accordance with the Declaration of Helsinki. The participating sites will be contacted regarding important protocol changes, both orally and in writing, and the trial registry database will be updated accordingly. Study results will be presented at relevant conferences, and submitted to peer-reviewed journals with open access in the fields of endocrinology, paediatrics and nutrition. After the appropriate embargo period, the results will be communicated to participants, healthcare professionals at the maternal healthcare centres, the public and other relevant groups, such as the national guideline group for thyroid and pregnancy and the National Food Agency.NCT02378246; Pre-results.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Allmänmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- General Practice (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
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University of Gothenburg
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