Iodine BioavailabilityBICOMNCT03590431
Bioavailability of Iodine in Cow's Milk in Swiss Adults
A study testing extrinsic iodine in milk, intrinsic iodine in milk and water iodine solution in people with Iodine Bioavailability, run by Isabelle Herter-Aeberli at 1 site in Switzerland.
Trial summary
Iodine deficiency remains a global problem impairing health and development in affected populations. Although there has been remarkable global progress against iodine deficiency, mild and moderate iodine deficiency remain common globally, including European countries. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Bioavailability
- What is being tested?
- extrinsic iodine in milk, intrinsic iodine in milk and water iodine solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jun 2018to 27 Sep 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 45 years
- BMI 19-25 kg/m2
- Current use of iodized salt at home
- Signed informed consent
Who cannot join
- Inadequate iodine status (defined as UIC <70 µg/L or >300 µg/L and assessed during screening from 5 urine spot samples)
- Exposure to iodine-containing X-ray/ computed tomography contrast agent
- Use of iodine-containing disinfectants (betadine)
- History of thyroid disease (according to the participants own statement)
- Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)
- Chronic use of medications (except for contraceptives)
Show all 12Show fewer
- Use of iodine containing supplements within 1 month prior to study start
- Pregnancy (according to the participants own statement but confirmed by a pregnancy test with the first urine spot sample from screening)
- Breast feeding
- Vegan diet
- Drug abuse
- Extensive alcohol intake, defined as more than 3 (men) or 2 (women) standard drinks per day (i.e. 3dl beer, 1dl wine, 3-4cl liquor), with less than 2 days per week without alcohol consumption
Trial locations and contacts
1 site in 1 country.
About this study
Iodine deficiency remains a global problem impairing health and development in affected populations. Although there has been remarkable global progress against iodine deficiency, mild and moderate iodine deficiency remain common globally, including European countries. Besides salt, milk and dairy products are important iodine sources in many industrialized countries, with varying contributions depending on the milk iodine concentration and the amount of milk and dairy consumed.
Iodine absorption in humans depends on the iodine species and possibly on the iodine status of the person. Very little data is available on iodine absorption or bioavailability from different dietary sources including milk. Inorganic iodide is thought to be absorbed almost completely (>90%). In contrast, only about two-thirds of some forms of organically-bound iodine are absorbed. The absorption of iodine from milk has not been quantified in humans. In this balance study, the investigators want to quantify the absorption of iodine in cow's milk in male and female adults and compare with the bioavailability from an iodine water solution (potassium iodide). The results of this study will inform on the bioavailability rate of iodine from cow's milk. Knowing the actual iodine bioavailability from milk is critical because milk and dairy products are major iodine sources in many industrialized countries.
The primary objective of this randomized, cross-over design study is to assess iodine bioavailability (measured using excretion in urine) from whole cow's milk delivering an iodine level of about 600 µg/L and compare them with a control iodine solution. The investigators will test three drinks within one subject: 1) a milk with an intrinsic iodine concentration of about 600 µg/L; 2) a milk with a naturally low iodine concentration and an added amount of potassium iodide (extrinsic iodine in milk matrix) to reach a level of about 600 µg/L (adapted to the intrinsic concentration in 1)); and 3) control iodine solution (extrinsic iodine in water matrix) with the same iodine concentration.
- Conditions
- Iodine Bioavailability
- Being tested
- extrinsic iodine in milk, intrinsic iodine in milk, water iodine solution
- Keywords
- iodine, bioavailability, milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extrinsic iodine in milkDietary supplement
300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine, low protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 50 µg/L. The iodine content of the extrinsically labelled milk will be adjusted to the required concentration (same as intrinsic iodine milk) by adding iodine in form of potassium iodide.
intrinsic iodine in milkDietary supplement
300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine, high protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 600 µg/L. This concentration will define final supplemental iodine given to the participants (adapting the total portion size).
water iodine solutionDietary supplement
300 ml water delivering ≈ 200 µg iodine (control)
| Study group | Role | What they receive |
|---|---|---|
| bioavailability iodine milk (extrinsic) | Other | 300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine in milk, low protein-bound fraction) Receives: Dietary Supplement: extrinsic iodine in milk |
| bioavailability iodine milk (intrinsic) | Other | 300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine in milk, high protein-bound fraction) Receives: Dietary Supplement: intrinsic iodine in milk |
| bioavailability water iodine solution | Other | 300 ml water iodine solution delivering ≈ 200 µg iodine (water iodine solution) Receives: Dietary Supplement: water iodine solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iodine concentration in urine
measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.
Measured: Days 1, 2, 3, 8, 9, 10, 15, 16 and 17
Secondary outcomes (3)
TSH
thyroid function test at baseline
Measured: day 1
T4
thyroid function test at baseline
Measured: day 1
iodine content of standardized diet
the quantitative assessment of iodine content in the participants' standardized diet
Measured: prior to study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start18 Jun 2018
- Primary completion27 Sep 2018
- Study completion27 Sep 2018
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 Iodine BioavailabilityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isabelle Herter-Aeberli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Herter-Aeberli, Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590431
- Sponsor's protocol ID
- BICOM 2018-00130
- Acronym
- BICOM
- Status last verified
- Jan 2019
- First submitted
- 30 May 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van der Reijden OL, Galetti V, Burki S, Zeder C, Krzystek A, Haldimann M, Berard J, Zimmermann MB, Herter-Aeberli I. Iodine bioavailability from cow milk: a randomized, crossover balance study in healthy iodine-replete adults. Am J Clin Nutr. 2019 Jul 1;110(1):102-110. doi: 10.1093/ajcn/nqz092.
PubMed 31788697
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Iodine in Cow's Milk in Swiss Adults
- ClinicalTrials.gov ID
- NCT03590431
- Acronym / sponsor ID
- BICOM / BICOM 2018-00130
- Conditions
- Iodine Bioavailability
- Keywords
- iodine, bioavailability, milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Isabelle Herter-AeberliUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 27 Sep 2018 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 18 Jul 2018 (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.
Iodine deficiency remains a global problem impairing health and development in affected populations. Although there has been remarkable global progress against iodine deficiency, mild and moderate iodine deficiency remain common globally, including European countries. Besides salt, milk and dairy products are important iodine sources in many industrialized countries, with varying contributions depending on the milk iodine concentration and the amount of milk and dairy consumed.
Iodine absorption in humans depends on the iodine species and possibly on the iodine status of the person. Very little data is available on iodine absorption or bioavailability from different dietary sources including milk. Inorganic iodide is thought to be absorbed almost completely (>90%). In contrast, only about two-thirds of some forms of organically-bound iodine are absorbed. The absorption of iodine from milk has not been quantified in humans. In this balance study, the investigators want to quantify the absorption of iodine in cow's milk in male and female adults and compare with the bioavailability from an iodine water solution (potassium iodide). The results of this study will inform on the bioavailability rate of iodine from cow's milk. Knowing the actual iodine bioavailability from milk is critical because milk and dairy products are major iodine sources in many industrialized countries.
The primary objective of this randomized, cross-over design study is to assess iodine bioavailability (measured using excretion in urine) from whole cow's milk delivering an iodine level of about 600 µg/L and compare them with a control iodine solution. The investigators will test three drinks within one subject: 1) a milk with an intrinsic iodine concentration of about 600 µg/L; 2) a milk with a naturally low iodine concentration and an added amount of potassium iodide (extrinsic iodine in milk matrix) to reach a level of about 600 µg/L (adapted to the intrinsic concentration in 1)); and 3) control iodine solution (extrinsic iodine in water matrix) with the same iodine concentration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bioavailability iodine milk (extrinsic) | Other | Dietary Supplement: extrinsic iodine in milk300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine in milk, low protein-bound fraction) |
| bioavailability iodine milk (intrinsic) | Other | Dietary Supplement: intrinsic iodine in milk300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine in milk, high protein-bound fraction) |
| bioavailability water iodine solution | Other | Dietary Supplement: water iodine solution300 ml water iodine solution delivering ≈ 200 µg iodine (water iodine solution) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged between 18 and 45 years
- BMI 19-25 kg/m2
- Current use of iodized salt at home
- Signed informed consent
Key exclusion criteria (12 listed)
- Inadequate iodine status (defined as UIC <70 µg/L or >300 µg/L and assessed during screening from 5 urine spot samples)
- Exposure to iodine-containing X-ray/ computed tomography contrast agent
- Use of iodine-containing disinfectants (betadine)
- History of thyroid disease (according to the participants own statement)
- Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)
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 |
|---|---|---|
| extrinsic iodine in milk300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine, low protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 50 µg/L. The iodine content of the extrinsically labelled milk will be adjusted to the required concentration (same as intrinsic iodine milk) by adding iodine in form of potassium iodide. | Dietary supplement | bioavailability iodine milk (extrinsic) |
| intrinsic iodine in milk300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine, high protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 600 µg/L. This concentration will define final supplemental iodine given to the participants (adapting the total portion size). | Dietary supplement | bioavailability iodine milk (intrinsic) |
| water iodine solution300 ml water delivering ≈ 200 µg iodine (control) | Dietary supplement | bioavailability water iodine solution |
Primary outcome
Iodine concentration in urine
Time frame: Days 1, 2, 3, 8, 9, 10, 15, 16 and 17
measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.
3 secondary outcomes
TSH
Time frame: day 1
T4
Time frame: day 1
iodine content of standardized diet
Time frame: prior to study start
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 Mar 2019.
- Derived from this study: PubMed 31788697van der Reijden OL, Galetti V, Burki S, Zeder C, Krzystek A, Haldimann M, Berard J, Zimmermann MB, Herter-Aeberli I. Iodine bioavailability from cow milk: a randomized, crossover balance study in healthy iodine-replete adults. Am J Clin Nutr. 2019 Jul 1;110(1):102-110. doi: 10.1093/ajcn/nqz092.
- Individual participant dataSharing planned: Undecided
Related trials for Iodine Bioavailability
Not yet recruiting
Bioavailability of Micronutrients With a Special Focus on Vitamin K Dependent on Consumed Diet
Micronutrient Status
Active, not recruiting
The Bioavailability of Iodine in Plant-based Milk Alternatives
Iodine Deficiency
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.
Isabelle Herter-Aeberli, Dr. principal investigator
University of 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 extrinsic iodine in milk, intrinsic iodine in milk and water iodine solution in people with Iodine Bioavailability, run by Isabelle Herter-Aeberli 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 4 inclusion and 12 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 Mar 2019. 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?
Iodine concentration in urine (time frame: Days 1, 2, 3, 8, 9, 10, 15, 16 and 17). 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 NCT03590431, 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 Mar 2019.