跳至主要内容
临床试验/NCT03590431
NCT03590431已完成不适用

Bioavailability of Iodine in Cow's Milk in Swiss Adults

Isabelle Herter-Aeberli2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
12
试验地点
2
主要终点
Iodine concentration in urine

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

盲法说明

Two of the three test drinks will consist of milk delivering extrinsic iodine or intrinsic iodine and will appear the same. These two milks will be labelled with "A" and "B" and masking will be applied to the participant only (single-blinded). The code will be held by the Study coordinator. However, for the water iodine-solution, blinding will not be possible.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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
  • 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

研究组 & 干预措施

bioavailability iodine milk (extrinsic)

Other

300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine in milk, low protein-bound fraction)

干预措施: extrinsic iodine in milk (Dietary Supplement)

bioavailability iodine milk (intrinsic)

Other

300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine in milk, high protein-bound fraction)

干预措施: intrinsic iodine in milk (Dietary Supplement)

bioavailability water iodine solution

Other

300 ml water iodine solution delivering ≈ 200 µg iodine (water iodine solution)

干预措施: water iodine solution (Dietary Supplement)

结局指标

主要结局

Iodine concentration in urine

时间窗: 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.

次要结局

  • T4(day 1)
  • iodine content of standardized diet(prior to study start)
  • TSH(day 1)

研究者

发起方
Isabelle Herter-Aeberli
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Isabelle Herter-Aeberli

Principal Investigator

Swiss Federal Institute of Technology

研究点 (2)

Loading locations...

相似试验