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OpenTrials
Completed

NCT Number: NCT03590431

Bioavailability of Iodine in Cow's Milk in Swiss Adults

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zürich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 45 years
  • BMI 19-25 kg/m2
  • Current use of iodized salt at home
  • Signed informed consent

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

extrinsic iodine in milk

Dietary 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 milk

Dietary 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 solution

Dietary Supplement

300 ml water delivering ≈ 200 µg iodine (control)

Primary outcomes

  1. 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.

Secondary outcomes

  1. TSH

    Time frame: day 1

    thyroid function test at baseline

  2. T4

    Time frame: day 1

    thyroid function test at baseline

  3. iodine content of standardized diet

    Time frame: prior to study start

    the quantitative assessment of iodine content in the participants' standardized diet

Other outcomes

  1. Age

    Time frame: at screening

    Age in years

  2. BMI

    Time frame: at screening

    BMI calculated from measured weight and height

Sponsors and collaborators

Lead sponsor

Isabelle Herter-Aeberli

Other

Registry information

Acronym: BICOM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2018
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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