Bioavailability of Iodine in Cow's Milk in Swiss Adults

Iodine Bioavailability Clinical Trial

— BICOM  

Official title:

Bioavailability of Iodine in Cow's Milk in Swiss Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03590431
• Other study ID #: BICOM 2018-00130
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: September 27, 2018

Study information

• Verified date: January 2019
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 27, 2018
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Aged between 18 and 45 years

2. BMI 19-25 kg/m2

3. Current use of iodized salt at home

4. Signed informed consent

Exclusion Criteria:

1. Inadequate iodine status (defined as UIC <70 µg/L or >300 µg/L and assessed during screening from 5 urine spot samples)

2. Exposure to iodine-containing X-ray/ computed tomography contrast agent

3. Use of iodine-containing disinfectants (betadine)

4. History of thyroid disease (according to the participants own statement)

5. Any metabolic, gastrointestinal or chronic disease such as diabetes, hepatitis, hypertension, or cancer (according to the participants own statement)

6. Chronic use of medications (except for contraceptives)

7. Use of iodine containing supplements within 1 month prior to study start

8. Pregnancy (according to the participants own statement but confirmed by a pregnancy test with the first urine spot sample from screening)

9. Breast feeding

10. Vegan diet

11. Drug abuse

12. 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

Related Conditions & MeSH terms

• Iodine Bioavailability

Intervention

Dietary Supplement:
• extrinsic iodine in milk
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
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
300 ml water delivering ˜ 200 µg iodine (control)

Locations

Country	Name	City	State
Switzerland	ETH Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Isabelle Herter-Aeberli

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age in years	at screening
Other	BMI	BMI calculated from measured weight and height	at screening
Primary	Iodine concentration in urine	measured by Sandell-Kolthoff method, mikrograms per liter To calculate iodine absorption, excretion and retention.	Days 1, 2, 3, 8, 9, 10, 15, 16 and 17
Secondary	TSH	thyroid function test at baseline	day 1
Secondary	T4	thyroid function test at baseline	day 1
Secondary	iodine content of standardized diet	the quantitative assessment of iodine content in the participants' standardized diet	prior to study start