Assessment of the Daily Average Requirement of Iodine in Lactating Women (NCT05382793) | Clinical Trial Compass
CompletedNot Applicable
Assessment of the Daily Average Requirement of Iodine in Lactating Women
Switzerland17 participantsStarted 2022-05-06
Plain-language summary
Human milk is the only source of iodine during early infancy and adequate iodine intake during lactation is necessary to assure optimal thyroid function in breastfed infants. However, the physiological requirement of iodine in lactating women is uncertain and recommendations for the daily dietary average requirement are poorly defined. WHO recommends iodine supplementation to lactating women in populations with incomplete coverage of iodized salt and deficient iodine intake, but the scientific evidence is weak and the optimal dose is uncertain.
The primary objective is to assess the daily dietary average requirement for iodine in lactating women.
Secondary objectives are to:
* Estimate the daily average requirement for iodine in exclusively breastfed infants;
* Assess the dose-response of dietary iodine supplements on breast milk iodine concentration in lactating women with adequate and inadequate habitual iodine intakes;
* Estimate the maternal iodine intake required to provide exclusively breastfed infants with an adequate iodine intake via breast milk.
Who can participate
Age range18 Years β 49 Years
SexFEMALE
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Inclusion criteria
β. Consent to enroll herself and her baby;
β. Age 18 to 49 years;
β. Singleton pregnancy;
β. Exclusively breastfeeding;
β. Self-estimated BMI \<30 kg/m2 before conception.
Exclusion criteria
β. TSH \>6 mIU/L;
β. Anemia (Hb \<11.7 g/L);
β. Pregnancy (self-reported);
β. Acute illness (e.g. gastroenteritis);
β. History of thyroid disease, diabetes, metabolic disease or inflammatory bowel disease (self-reported);