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.
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
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).
- Conditions
- Selenium and Iodine Status
- 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 group | Role | What they receive |
|---|---|---|
| Milk treatment group | Active comparator | Semi-skimmed cow's milk + normal diet for 12 weeks Receives: Other: Semi-skimmed cow's milk |
| Control group | No intervention | Normal diet for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
Measured: Change from baseline following 12-week intervention
Secondary outcomes (7)
Serum thyroid hormone analysis
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Urinary creatinine analysis
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Serum selenoprotein P analysis
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Dietary iodine and selenium intake
24-hour dietary recall
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Blood pressure
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Body Mass Index
Measured: Baseline (week 0), mid (week 6) and post-intervention (week 12)
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.
- First posted10 May 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
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 Selenium and Iodine StatusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Council for Northern Ireland, LGC Limited, University Hospital Southampton NHS Foundation Trust, Northern Health and Social Care Trust, Department of Agriculture and Rural Development Northern Ireland, Charite University, Berlin, Germany
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Cow's Milk to Iodine and Selenium Status in Women of Child-bearing Age
- ClinicalTrials.gov ID
- NCT02767167
- Acronym / sponsor ID
- SIMI / REC/15/0042
- Conditions
- Selenium and Iodine Status
- Keywords
- Cow's milk, Iodine, Selenium, Women, Child-bearing age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Dairy Council for Northern Ireland, LGC Limited, University Hospital Southampton NHS Foundation Trust, Northern Health and Social Care Trust, Department of Agriculture and Rural Development Northern Ireland, Charite University, Berlin, Germany
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 May 2016 (estimated)
- 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 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk treatment group | Active comparator | Other: Semi-skimmed cow's milkSemi-skimmed cow's milk + normal diet for 12 weeks |
| Control group | No intervention | –Normal diet for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy
- Age 18-45 years
- Females
- Non smoking
- No history of thyroid or gastrointestinal conditions
Key exclusion criteria (8 listed)
- Smoker
- Pregnant, breastfeeding or planning to become pregnant during the study
- Milk allergy
- Non-milk consumers or vegans
- Lactose intolerant individuals
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 |
|---|---|---|
| Semi-skimmed cow's milk430ml of semi-skimmed cow's milk / day for 12 weeks | Other | Milk treatment group |
Primary outcome
Urinary iodine concentration
Time frame: Change from baseline following 12-week intervention
7 secondary outcomes
Serum thyroid hormone analysis
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Urinary creatinine analysis
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Serum selenoprotein P analysis
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Dietary iodine and selenium intake
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Blood pressure
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Body Mass Index
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
Waist Hip ratio
Time frame: Baseline (week 0), mid (week 6) and post-intervention (week 12)
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 10 May 2016.
- Derived from this study: PubMed 29546298O'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.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.