Iodine Deficiency Clinical Trial
Official title:
Nutritional Status of Iodine in the Pregnant Population of Catalonia: a Study of Dietary Habits and Urinary Iodine
The purpose of this study is to assess the effectiveness of individual education versus group education about dietary habits and iodine supplementation to decrease iodine deficiency in pregnant women
BACKGROUND: It is a priority to achieve an adequate nutritional status of iodine during
pregnancy since iodine deficiency in this population may have repercussions on the mother
during both gestation and post partum as well as on the foetus, the neonate and the child at
different ages. According to the WHO, iodine deficiency is the most frequent cause of mental
retardation and irrreversible cerebral lesions around the world. However, few studies have
been published on the nutritional status of iodine in the pregnant population within the
Primary Care setting, a health care level which plays an essential role in the education and
control of pregnant women.
AIMS: 1.- To know the hygiene-dietetic habits related to the intake of foods rich in iodine
and smoking during pregnancy. 2.- To determine the prevalence of iodine deficiency and the
factors associated with its appearance during pregnancy.
METHODS/DESIGN: We will perform a cluster randomised, controlled, multicentre trial.
Randomisation unit: Primary Care Team. Study population: 898 pregnant women over the age of
17 years attending consultation to a midwife during the first trimester of pregnancy in the
participating primary care centres. Outcome measures: consumption of iodine-rich foods and
iodine deficiency. Points of assessment: each trimester of the gestation. Intervention: group
education during the first trimester of gestation on healthy hygiene-dietetic habits and the
importance of an adequate iodine nutritional status. Statistical analysis: descriptive
analysis of all variables will be performed as well as multilevel logistic regression. All
analyses will be done carried out on an intention to treat basis and will be fitted for
potential confounding factors and variables of clinical importance.
DISCUSSION: Evidence of generalised iodine deficiency during pregnancy could lead to the
promotion of interventions of prevention such as how to improve and intensify health care
educational programmes for pregnant women.
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