Focus: Establish the Iodine Requirement During InfancyNCT02045784
Establishing the Iodine Requirement in Infancy
A study testing Infant formula and Breast milk in people with Focus: Establish the Iodine Requirement During Infancy, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
Trial summary
The objective of this study is to define the amount of dietary iodine needed per day during the first six months of life. The hypothesis is that the current recommended iodine intake in infants is set too high. Read more about this study
- Who is it for?
- Ages 5 to 14 weeksHealthy volunteers can take part
- Conditions the study is for
- Focus: Establish the Iodine Requirement During Infancy
- What is being tested?
- Infant formula and Breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2014to Dec 2016
- 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 5 to 14 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy mother/infant pairs (considering the following criteria: normal thyroid function, adequate iron status, no apparent infection)
- Full term birth (in week 38 to 42), birth weight >2 500 g, singleton birth
- No known family history of thyroid disease
- Infant does not have persistent stomach and/or intestine symptoms
- Mother did not use: a) X-ray or CT contrast agent (both may contain iodine); b) iodine containing medication within the last year
- Formula fed infants study arm: Infant is fully formula fed and was already formula fed prior to the study
Show all 9Show fewer
- Formula fed infants study arm: Infant was fed with formula based on cow's milk protein prior to the study
- Formula fed infants study arm: Infant shows no signs of cow's milk allergy
- Breast fed infants study arm: Infant is fully breast fed and was fully breast fed prior to the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
North-West University South Africa
Potchefstroom, 2520
About this study
Official title: Establishing the Iodine Requirement in Infancy: a Double-blind Dose-response, Cross-over Balance Study
The objective of this study is to define the amount of dietary iodine needed per day during the first six months of life. The hypothesis is that the current recommended iodine intake in infants is set too high.
Read the detailed description
Iodine is an essential trace element for human health and an integral component of the thyroid hormones. Thyroid hormones regulate normal growth and development, particularly of the brain. Iodine deficiency results in low levels of thyroid hormones that can impair brain development and lower intelligence. Infants have only small iodine stores at birth and are entirely dependent on iodine provided by breast milk or infant formula. However, the exact amount of daily iodine that infants need for healthy development is poorly understood and there is insufficient data to define an Estimated Average Requirement (EAR) for this age group.
The current recommendation for dietary iodine intake for 0-6 month (mo) old infants of 110 µg/day is only an adequate intake (AI), in the absence of an EAR. This AI is based on the iodine intake in breast fed infants from breast milk iodine concentration (BMIC) measured in U.S. women during a period when overall iodine intakes in the U.S. population were excessive. The AI sharply disagrees with the current WHO recommendation for assessment of infant iodine nutrition based on excretion of iodine in the urine. The discrepancy makes assessment and monitoring of iodine status at this age problematic and has led to major confusion on how to interpret adequate iodine intake and optimal iodine status.
The objective of this study is to measure the daily iodine retention from dietary iodine and define the physiological iodine requirement (the EAR) during the first six months of life. The study hypothesis is that the AI is set too high and its use in assessing iodine intake and status overestimates the prevalence of iodine deficiency in infants.
The study will be a metabolic balance study of breast milk consumption and three dose-response cross-over arms of iodine enriched infant formula milk in 60 healthy 2-3 mo old infants (30 breast fed and 30 formula fed). Breast fed infants will be exclusively and unrestrictedly breast fed by the mother and the breast milk consumption will be monitored for 4 days by weighing the infants before and after each feeding session. Formula fed infants will be randomly allocated to three 11 days cross-over periods of exclusive consumption of infant formula milks (IFM) providing 60 µg I/day, 110 µg I/day and 220 µg I/day. The iodine intake will be monitored by recording the amount of infant formula milk fed to the infants. The iodine excretion will be measured from complete collections of urine and feces for a 4-day period for each arm. The iodine retention will be calculated from the difference between measured iodine intake and excretion. Analytical determination of the iodine content in biological samples will be done by mass spectrometry after digestion and iodine extraction. The sample size is based on an estimated dose-response of the different levels of dietary iodine on iodine excretion.
- Being tested
- Infant formula, Breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaDietary supplement
To establish dose-response relationships, formula-fed infants will be randomly allocated to three 11-day cross-over periods of exclusive consumption of infant formula providing different amounts of iodine. All iodine levels are within the required iodine levels for infant formula following the regulations of the United States, the European Union, Switzerland and New Zealand.
Breast milkOther
Unlimited breast feeding
| Study group | Role | What they receive |
|---|---|---|
| Infant formula milk 60 µg iodine/day | Experimental | Infant formula containing 57 µg/100 g powder, providing approximately 60 µg iodine/day (i.e. 55% of the current AI). Unrestricted consumption during 11 days. Receives: Dietary Supplement: Infant formula |
| Infant formula milk 110 µg iodine/day | Experimental | Infant formula containing 92 µg/100 g powder, providing approximately 110 µg iodine/day (i.e. 100% of the current AI). Unrestricted consumption during 11 days. Receives: Dietary Supplement: Infant formula |
| Infant formula 220 µg iodine/day | Experimental | Infant formula containing 217 µg/100 g powder, providing approximately 220 µg iodine/day (i.e. 200% of the current AI). Unrestricted consumption during 11 days. Receives: Dietary Supplement: Infant formula |
| Breast milk | Other | Unrestricted consumption during 4 days Receives: Other: Breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine retention
The amount of iodine retained will be calculated as the difference between measured iodine intake and measured iodine excretion
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focus: Establish the Iodine Requirement During InfancyStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- North-West University, South Africa
- Responsible party
- Principal investigator, Maria Andersson, Swiss Federal Institute of Technology
- Investigators
- Maria Andersson, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045784
- Sponsor's protocol ID
- EK 2013-N-21
- Status last verified
- Nov 2017
- First submitted
- 22 Jan 2014
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27.
PubMed 27465383
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Iodine Requirement in Infancy: a Double-blind Dose-response, Cross-over Balance Study
- ClinicalTrials.gov ID
- NCT02045784
- Acronym / sponsor ID
- EK 2013-N-21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- North-West University, South Africa
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Jan 2014 (estimated)
- 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.
The objective of this study is to define the amount of dietary iodine needed per day during the first six months of life. The hypothesis is that the current recommended iodine intake in infants is set too high.
Detailed description
Iodine is an essential trace element for human health and an integral component of the thyroid hormones. Thyroid hormones regulate normal growth and development, particularly of the brain. Iodine deficiency results in low levels of thyroid hormones that can impair brain development and lower intelligence. Infants have only small iodine stores at birth and are entirely dependent on iodine provided by breast milk or infant formula. However, the exact amount of daily iodine that infants need for healthy development is poorly understood and there is insufficient data to define an Estimated Average Requirement (EAR) for this age group.
The current recommendation for dietary iodine intake for 0-6 month (mo) old infants of 110 µg/day is only an adequate intake (AI), in the absence of an EAR. This AI is based on the iodine intake in breast fed infants from breast milk iodine concentration (BMIC) measured in U.S. women during a period when overall iodine intakes in the U.S. population were excessive. The AI sharply disagrees with the current WHO recommendation for assessment of infant iodine nutrition based on excretion of iodine in the urine. The discrepancy makes assessment and monitoring of iodine status at this age problematic and has led to major confusion on how to interpret adequate iodine intake and optimal iodine status.
The objective of this study is to measure the daily iodine retention from dietary iodine and define the physiological iodine requirement (the EAR) during the first six months of life. The study hypothesis is that the AI is set too high and its use in assessing iodine intake and status overestimates the prevalence of iodine deficiency in infants.
The study will be a metabolic balance study of breast milk consumption and three dose-response cross-over arms of iodine enriched infant formula milk in 60 healthy 2-3 mo old infants (30 breast fed and 30 formula fed). Breast fed infants will be exclusively and unrestrictedly breast fed by the mother and the breast milk consumption will be monitored for 4 days by weighing the infants before and after each feeding session. Formula fed infants will be randomly allocated to three 11 days cross-over periods of exclusive consumption of infant formula milks (IFM) providing 60 µg I/day, 110 µg I/day and 220 µg I/day. The iodine intake will be monitored by recording the amount of infant formula milk fed to the infants. The iodine excretion will be measured from complete collections of urine and feces for a 4-day period for each arm. The iodine retention will be calculated from the difference between measured iodine intake and excretion. Analytical determination of the iodine content in biological samples will be done by mass spectrometry after digestion and iodine extraction. The sample size is based on an estimated dose-response of the different levels of dietary iodine on iodine excretion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infant formula milk 60 µg iodine/day | Experimental | Dietary Supplement: Infant formulaInfant formula containing 57 µg/100 g powder, providing approximately 60 µg iodine/day (i.e. 55% of the current AI). Unrestricted consumption during 11 days. |
| Infant formula milk 110 µg iodine/day | Experimental | Dietary Supplement: Infant formulaInfant formula containing 92 µg/100 g powder, providing approximately 110 µg iodine/day (i.e. 100% of the current AI). Unrestricted consumption during 11 days. |
| Infant formula 220 µg iodine/day | Experimental | Dietary Supplement: Infant formulaInfant formula containing 217 µg/100 g powder, providing approximately 220 µg iodine/day (i.e. 200% of the current AI). Unrestricted consumption during 11 days. |
| Breast milk | Other | Other: Breast milkUnrestricted consumption during 4 days |
Who may qualify
- Ages
- 5 to 14 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Healthy mother/infant pairs (considering the following criteria: normal thyroid function, adequate iron status, no apparent infection)
- Full term birth (in week 38 to 42), birth weight >2 500 g, singleton birth
- No known family history of thyroid disease
- Infant does not have persistent stomach and/or intestine symptoms
- Mother did not use: a) X-ray or CT contrast agent (both may contain iodine); b) iodine containing medication within the last year
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Infant formulaTo establish dose-response relationships, formula-fed infants will be randomly allocated to three 11-day cross-over periods of exclusive consumption of infant formula providing different amounts of iodine. All iodine levels are within the required iodine levels for infant formula following the regulations of the United States, the European Union, Switzerland and New Zealand. | Dietary supplement | Infant formula 220 µg iodine/day, Infant formula milk 110 µg iodine/day, Infant formula milk 60 µg iodine/day |
| Breast milkUnlimited breast feeding | Other | Breast milk |
Primary outcome
Iodine retention
Time frame: 4 days
The amount of iodine retained will be calculated as the difference between measured iodine intake and measured iodine excretion
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 8 Nov 2017.
- Derived from this study: PubMed 27465383Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27.
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.
Maria Andersson, PhD principal investigator
ETH Zurich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula and Breast milk in people with Focus: Establish the Iodine Requirement During Infancy, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
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 0 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 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, 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?
Iodine retention (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045784, which also lists 1 linked publication.
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 8 Nov 2017.