HealthyLISANCT05382793
Assessment of the Daily Average Requirement of Iodine in Lactating Women
A study testing Iodide (150 μg/day) and Iodine (300 μg/day) in people with Healthy and Iodine Deficiency, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Iodine Deficiency
- What is being tested?
- Iodide (150 μg/day) and Iodine (300 μg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 May 2022to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent to enroll herself and her baby;
- Age 18 to 49 years;
- Singleton pregnancy;
- Exclusively breastfeeding;
- Self-estimated BMI <30 kg/m2 before conception.
- Full term (38-42 weeks);
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- Birthweight ≥2.5 kg;
- Exclusively breastfed;
- Age 0-10 weeks at recruitment.
Who cannot join
- 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);
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nutrition Research Unit, University Children's Hospital Zurich
Zurich, 8032
About this study
Official title: 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.
Read more
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.
Read the 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 receding in Zürich, Switzerland. The study involves an initial screening, a 2 weeks run-in period and a balance period over 3 weeks. Participating women will be allocated to two groups based on their consumption of dietary iodine supplements during pregnancy. Women who consumed daily iodine supplements during pregnancy will be assigned to group 1 (n=12) and receive daily supplements containing 150 µg iodine for 2 weeks, whereas women who did not will be enrolled in group 2 and will receive no supplement during the run-in period. Breast milk and spot urine samples (mothers and infants) will be collected daily in all participants during two weeks for the measurement of breast milk and urinary iodine concentrations. During the balance period, all women will receive either no supplement, iodine supplements providing 150 µg/day, or 300 µg/day in random order with cross-over design. Each supplement dose will be assessed in a test period of 7 days, including 2 run-in days, 3 balance days and 2 wash-out days. The supplements will be consumed during the first 5 days in each test-period. During the 3 balance days, the daily iodine intake and excretion will be measured in mothers and infants, and the iodine retention will be calculated for each regimen and study group. The minimum daily average requirement will be determined as the iodine intake where the iodine retention is zero.
- Conditions
- Healthy, Iodine Deficiency
- Being tested
- Control, Iodide (150 μg/day), Iodine (300 μg/day)
- Keywords
- Iodine, Dietary requirement, Lactating women, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
No iodine
Iodide (150 μg/day)Dietary supplement
Also called Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, Germany
A single oral tablet once daily for five days providing 150 μg iodine as potassium iodide
Iodine (300 μg/day)Dietary supplement
Also called Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, Germany
Two oral tablets (150 μg + 150 μg) daily for five days providing 300 μg iodine as potassium iodide
| Study group | Role | What they receive |
|---|---|---|
| Lactating women with assumed adequate habitual iodine intake | Experimental | 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. Receives: Dietary Supplement: Control; Dietary Supplement: Iodide (150 μg/day); Dietary Supplement: Iodine (300 μg/day) |
| Lactating mothers with assumed inadequate habitual iodine intake | Experimental | Women who did not consume iodine-containing dietary supplements during pregnancy (≥150 μg/day). Receives: Dietary Supplement: Control; Dietary Supplement: Iodide (150 μg/day); Dietary Supplement: Iodine (300 μg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal iodine retention (μg/day)
Calculated as iodine intake (µg/day) minus the iodine excretion (µg/day)
Measured: 24 hours
Secondary outcomes (2)
Maternal iodine excretion in breast milk (μg/day)
Estimated from measured breast milk iodine concentration (μg/L) and breast milk volume (L)
Measured: 24 hours
Infant iodine retention (μg/day)
Calculated as iodine intake (µg/day) minus the iodine excretion (µg/day)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start6 May 2022
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, controlled, dose-response metabolic balance study with cross-over design
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Responsible party
- Sponsor
- Investigators
- Christian Braegger, M.D., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382793
- Sponsor's protocol ID
- BASEC2022-00130
- Acronym
- LISA
- Status last verified
- Aug 2025
- First submitted
- 16 May 2022
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Daily Average Requirement of Iodine in Lactating Women: A Dose-response Metabolic Balance Study
- ClinicalTrials.gov ID
- NCT05382793
- Acronym / sponsor ID
- LISA / BASEC2022-00130
- Conditions
- Healthy, Iodine Deficiency
- Keywords
- Iodine, Dietary requirement, Lactating women, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 receding in Zürich, Switzerland. The study involves an initial screening, a 2 weeks run-in period and a balance period over 3 weeks. Participating women will be allocated to two groups based on their consumption of dietary iodine supplements during pregnancy. Women who consumed daily iodine supplements during pregnancy will be assigned to group 1 (n=12) and receive daily supplements containing 150 µg iodine for 2 weeks, whereas women who did not will be enrolled in group 2 and will receive no supplement during the run-in period. Breast milk and spot urine samples (mothers and infants) will be collected daily in all participants during two weeks for the measurement of breast milk and urinary iodine concentrations. During the balance period, all women will receive either no supplement, iodine supplements providing 150 µg/day, or 300 µg/day in random order with cross-over design. Each supplement dose will be assessed in a test period of 7 days, including 2 run-in days, 3 balance days and 2 wash-out days. The supplements will be consumed during the first 5 days in each test-period. During the 3 balance days, the daily iodine intake and excretion will be measured in mothers and infants, and the iodine retention will be calculated for each regimen and study group. The minimum daily average requirement will be determined as the iodine intake where the iodine retention is zero.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, controlled, dose-response metabolic balance study with cross-over design
| Arm | Type | Receives |
|---|---|---|
| Lactating women with assumed adequate habitual iodine intake | Experimental | Dietary Supplement: Control, Dietary Supplement: Iodide (150 μg/day), Dietary Supplement: Iodine (300 μg/day)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. |
| Lactating mothers with assumed inadequate habitual iodine intake | Experimental | Dietary Supplement: Control, Dietary Supplement: Iodide (150 μg/day), Dietary Supplement: Iodine (300 μg/day)Women who did not consume iodine-containing dietary supplements during pregnancy (≥150 μg/day). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Consent to enroll herself and her baby;
- Age 18 to 49 years;
- Singleton pregnancy;
- Exclusively breastfeeding;
- Self-estimated BMI <30 kg/m2 before conception.
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlNo iodine | Dietary supplement | Lactating mothers with assumed inadequate habitual iodine intake, Lactating women with assumed adequate habitual iodine intake |
| Iodide (150 μg/day)Also: Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, GermanyA single oral tablet once daily for five days providing 150 μg iodine as potassium iodide | Dietary supplement | Lactating mothers with assumed inadequate habitual iodine intake, Lactating women with assumed adequate habitual iodine intake |
| Iodine (300 μg/day)Also: Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, GermanyTwo oral tablets (150 μg + 150 μg) daily for five days providing 300 μg iodine as potassium iodide | Dietary supplement | Lactating mothers with assumed inadequate habitual iodine intake, Lactating women with assumed adequate habitual iodine intake |
Primary outcome
Maternal iodine retention (μg/day)
Time frame: 24 hours
Calculated as iodine intake (µg/day) minus the iodine excretion (µg/day)
2 secondary outcomes
Maternal iodine excretion in breast milk (μg/day)
Time frame: 24 hours
Infant iodine retention (μg/day)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Braegger, M.D. principal investigator
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodide (150 μg/day) and Iodine (300 μg/day) in people with Healthy and Iodine Deficiency, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal iodine retention (μg/day) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.