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Selenium and Iodine StatusSIMINCT02767167

Contribution of Cow's Milk to Iodine and Selenium Status in Women of Child-bearing Age

A study testing Semi-skimmed cow's milk in people with Selenium and Iodine Status, run by University of Ulster at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Iodine is an essential trace element necessary for the synthesis of thyroid hormones which are critical for human growth and development throughout the lifecycle. Iodine is particularly important during pregnancy and infancy for brain and neurological development. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Selenium and Iodine Status
What is being tested?
Semi-skimmed cow's milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteUnited Kingdom
Study dates
Sep 2015to Dec 2015
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
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy
  • Age 18-45 years
  • Females
  • Non smoking
  • No history of thyroid or gastrointestinal conditions
  • Not consuming thyroid medication or medication containing iodine or selenium
  • Willing to increase their milk consumption should they be randomised into the milk group

Who cannot join

  • Smoker
  • Pregnant, breastfeeding or planning to become pregnant during the study
  • Milk allergy
  • Non-milk consumers or vegans
  • Lactose intolerant individuals
  • Use of dietary supplements containing iodine or selenium in previous 3 months
  • Peri- or post-menopausal
  • Consume more than 250ml of milk daily

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Human Intervention Studies Unit, Ulster University

    Coleraine, Co.Londonderry, BT52 1SA

Other trials in United Kingdom

About this study

Iodine is an essential trace element necessary for the synthesis of thyroid hormones which are critical for human growth and development throughout the lifecycle. Iodine is particularly important during pregnancy and infancy for brain and neurological development. Severe iodine deficiency during pregnancy can cause severe mental impairment and stillbirth while mild-to-moderate deficiency has been associated with impaired infant development. As such, pregnant women and women of child-bearing age are particularly vulnerable to the effects of iodine deficiency.

Globally, 241 million (30%) school aged children are iodine deficient. Historically, the UK and Ireland were believed to be iodine sufficient but concern has been expressed in the last decade regarding the iodine status of the UK and Irish populations. A study of Irish women in 2004 reported 55% of pregnant women in their sample population to be moderately iodine deficient and 53% of non-pregnant women to be moderately iodine deficient. A study of UK schoolgirls found that 51% were mildly iodine deficient and 16% were moderately deficient. Importantly, the prevalence of iodine deficiency was highest in Northern Ireland where 85% of those sampled were iodine deficient.

Read more

Iodine is known to interact with selenium in the conversion of the thyroid hormone thyroxine (T4) to the metabolically active triiodothyonine (T3) hormone. Selenium is also important for immune, cardiovascular and cognitive function. Selenium status has been reported to be moderately low using pooled English data on blood selenium concentrations from 1984 to 1992. In addition, the latest National Diet and Nutrition Survey reports that selenium intakes are below recommendations for several population groups including women of childbearing age where mean selenium intakes are 76% of the recommended 60µg/day. This national survey also reported that 49% of women aged 19-64 years failed to meet the lower reference nutrient intake of 40µg/day.

Milk and dairy products are the major source of iodine for the UK population and are also a source of selenium. The contribution of milk and dairy products to iodine and selenium intakes is greatest in adult females (35% and 6% respectively). Observational evidence has repeatedly reported milk consumption to be positively correlated with iodine status and iodine intakes. Research in Iceland and New Zealand has reported that milk consumption is not associated with selenium status; however it is unknown if this is true for the UK population.

To date, no randomised controlled trial has examined the effect of milk consumption on either iodine or selenium status. The possibility of increasing iodine and selenium intake by increasing milk consumption, a widely available and consumed foodstuff, in a population group vulnerable to micronutrient deficiency should be investigated. This would add valuable data to the knowledge base for iodine, where there is ongoing debate over the most appropriate means of increasing iodine intake amongst women of childbearing age in the UK where salt iodisation, the key strategy in preventing deficiency, is not implemented.

The aim of this study is to investigate the impact of cow's milk consumption on the biological status of iodine and selenium among women of child-bearing age.

The study will be a 12 week randomised-controlled human intervention study. Participants will be randomised to consume additional semi-skimmed milk in the Following amounts, control group (0mls/day), intervention group (430mls/day or 3l per week).

Being tested
Semi-skimmed cow's milk
Keywords
Cow's milk, Iodine, Selenium, Women, Child-bearing age

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semi-skimmed cow's milkOther

    430ml of semi-skimmed cow's milk / day for 12 weeks

Study groups in NCT02767167
Study groupRoleWhat they receive
Milk treatment groupActive comparatorSemi-skimmed cow's milk + normal diet for 12 weeks
Receives: Other: Semi-skimmed cow's milk
Control groupNo interventionNormal diet for 12 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary iodine concentration

    Measured: Change from baseline following 12-week intervention

Secondary outcomes (7)
  1. Serum thyroid hormone analysis

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  2. Urinary creatinine analysis

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  3. Serum selenoprotein P analysis

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  4. Dietary iodine and selenium intake

    24-hour dietary recall

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  5. Blood pressure

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  6. Body Mass Index

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

  7. Waist Hip ratio

    Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767167
Sponsor's protocol ID
REC/15/0042
Acronym
SIMI
Status last verified
Apr 2016
First submitted
4 May 2016
Last updated
10 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • O'Kane SM, Pourshahidi LK, Mulhern MS, Strain JJ, Mackle EM, Koca D, Schomburg L, Hill S, O'Reilly J, Kmiotek D, Deitrich C, Bath SC, Yeates AJ. Cow Milk Consumption Increases Iodine Status in Women of Childbearing Age in a Randomized Controlled Trial. J Nutr. 2018 Mar 1;148(3):401-408. doi: 10.1093/jn/nxx043.

    PubMed 29546298

Questions about this trial

What is this clinical trial studying?

A study testing Semi-skimmed cow's milk in people with Selenium and Iodine Status, run by University of Ulster at 1 site in United Kingdom.

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 7 inclusion and 8 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 10 May 2016. 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 United Kingdom. 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?

Urinary iodine concentration (time frame: Change from baseline following 12-week intervention). 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 NCT02767167, 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 10 May 2016.

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