- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05382793
Assessment of the Daily Average Requirement of Iodine in Lactating Women (LISA)
Assessment of the Daily Average Requirement of Iodine in Lactating Women: A Dose-response Metabolic Balance Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maria Andersson, Dr. sc.
- Phone Number: +41442668462
- Email: maria.andersson@kispi.uzh.ch
Study Contact Backup
- Name: Lena Fischer, MSc
- Phone Number: +41442668462
- Email: lena.fischer@kispi.uzh.ch
Study Locations
-
-
-
Zürich, Switzerland, 8032
- Recruiting
- Nutrition Research Unit, University Children's Hospital Zurich
-
Contact:
- Maria Andersson, Dr. sc.
- Phone Number: +41442668462
- Email: maria.andersson@kispi.uzh.ch
-
Contact:
- Lena Fischer, MSc
- Phone Number: +41442668462
- Email: lena.fischer@kispi.uzh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lactating women with assumed adequate habitual iodine intake
Women who consumed iodine-containing dietary supplements during pregnancy (≥150 μg/day).
Women in this group will receive a daily oral iodine supplement providing 150 μg iodine as potassium iodide for 14 days before the study start.
|
No iodine
A single oral tablet once daily for five days providing 150 μg iodine as potassium iodide
Other Names:
Two oral tablets (150 μg + 150 μg) daily for five days providing 300 μg iodine as potassium iodide
Other Names:
|
Experimental: Lactating mothers with assumed inadequate habitual iodine intake
Women who did not consume iodine-containing dietary supplements during pregnancy (≥150 μg/day).
|
No iodine
A single oral tablet once daily for five days providing 150 μg iodine as potassium iodide
Other Names:
Two oral tablets (150 μg + 150 μg) daily for five days providing 300 μg iodine as potassium iodide
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal iodine retention (μg/day)
Time Frame: 24 hours
|
Calculated as iodine intake (µg/day) minus the iodine excretion (µg/day)
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal iodine excretion in breast milk (μg/day)
Time Frame: 24 hours
|
Estimated from measured breast milk iodine concentration (μg/L) and breast milk volume (L)
|
24 hours
|
Infant iodine retention (μg/day)
Time Frame: 24 hours
|
Calculated as iodine intake (µg/day) minus the iodine excretion (µg/day)
|
24 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christian Braegger, M.D., University Children's Hospital, Zurich
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BASEC2022-00130
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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