Status:
COMPLETED
Assessment of the Daily Average Requirement of Iodine in Lactating Women
Lead Sponsor:
University Children's Hospital, Zurich
Collaborating Sponsors:
ETH Zurich (Switzerland)
Conditions:
Healthy
Iodine Deficiency
Eligibility:
FEMALE
18-49 years
Phase:
NA
Brief 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 physiologica...
Detailed Description
This study is a single center, randomized, controlled, dose-response metabolic balance study with cross-over design. The study will be conducted in 24 exclusively breastfeeding women and their infants...
Eligibility Criteria
Inclusion
- Mother-infant pairs in good health, free of any acute illness or chronic thyroid disease.
- Mothers
- Inclusion criteria:
- Consent to enroll herself and her baby;
- Age 18 to 49 years;
- Singleton pregnancy;
- Exclusively breastfeeding;
- Self-estimated BMI \<30 kg/m2 before conception.
- Exclusion criteria:
- TSH \>6 mIU/L;
- Anemia (Hb \<11.7 g/L);
- Pregnancy (self-reported);
- Acute illness (e.g. gastroenteritis);
- History of thyroid disease, diabetes, metabolic disease or inflammatory bowel disease (self-reported);
- Currently smoking (\>1 cigarette/day);
- Drug abuse or extensive alcohol intake;
- Exposure to iodine-containing X-ray or computed tomography contrast agents during the past 6 months;
- Adenomatous goiter, dermatitis, anti-C1q-vasculitis.
- Infants
- Inclusion criteria:
- Full term (38-42 weeks);
- Birthweight ≥2.5 kg;
- Exclusively breastfed;
- Age 0-10 weeks at recruitment.
- Exclusion criteria:
- Age \>6 months;
- TSH \>10 mIU/L at neonatal screening at 2-5 days after birth (i.e. infants not requested to attend recall assessment);
- Diagnosed or suspected colic.
Exclusion
Key Trial Info
Start Date :
May 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05382793
Start Date
May 6 2022
End Date
December 15 2023
Last Update
September 3 2025
Active Locations (1)
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1
Nutrition Research Unit, University Children's Hospital Zurich
Zurich, Switzerland, 8032