Iodine DeficiencyNCT05170997
Strategies to Improve Iodine Status in Early Pregnancy
A study testing Cows' milk and British Dietetic Association Iodine Fact Sheet. in people with Iodine Deficiency and Pregnancy Related, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Pregnancy Related
- What is being tested?
- Cows' milk and British Dietetic Association Iodine Fact Sheet.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2021to 3 Aug 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women at 6-16 weeks pregnant
- women receiving antenatal care within Belfast Health and Social Care Trust
Who cannot join
- women with known thyroid disease currently taking thyroid medication
- women with type one diabetes
- women under 18 years of age
- those unable to provide informed consent
- women with abnormal thyroid function tests at booking appointment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Jubilee Maternity Hospital
Belfast, BT12 6BA
About this study
This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.
Read the detailed description
Women of child bearing age, and those who are currently pregnant, have been found to be iodine deficient in the United Kingdom (UK). Dairy products are an essential source of iodine in the UK as iodised salt is not widely available. This study will ask women in the intervention group to drink approximately one pint of milk a day for 12 weeks during pregnancy.
- Conditions
- Iodine Deficiency, Pregnancy Related
- Being tested
- Cows' milk, British Dietetic Association Iodine Fact Sheet.
- Keywords
- Iodine, Pregnancy, Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cows' milkDietary supplement
Intervention groups will receive a free 12 week supply of cows' milk equating to a pint a day for study participants. Milk is provided by Lakeland dairies.
British Dietetic Association Iodine Fact Sheet.Other
All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.
| Study group | Role | What they receive |
|---|---|---|
| Iodine Control | Active comparator | Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. Receives: Other: British Dietetic Association Iodine Fact Sheet. |
| No Iodine Control | Active comparator | Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. Receives: Other: British Dietetic Association Iodine Fact Sheet. |
| Iodine Intervention | Experimental | Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. Receives: Dietary Supplement: Cows' milk; Other: British Dietetic Association Iodine Fact Sheet. |
| No Iodine Intervention | Experimental | Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. Receives: Dietary Supplement: Cows' milk; Other: British Dietetic Association Iodine Fact Sheet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration
Proportion of the maternal cohort who achieve WHO urinary iodine concentration(UIC) of >=150 micrograms/litre on early morning spot urinary sampling at 12 weeks post intervention.
Measured: 18 months
Secondary outcomes (3)
Iodine knowledge
Knowledge regarding iodine intake in the diet in pregnancy and into postpartum assessed using an iodine knowledge questionnaire that will be completed by participants at the beginning and the end of the study period.
Measured: 24 months
Iodine intake
Intake of iodine rich foods at 29 weeks and postpartum in those who breastfeed will be assessed using four day food diaries at the beginning and end of the study, and validated iodine-specific food frequency questionnaires at the beginning of the study, at the end of the intervention period, six weeks after the end of the intervention period and at the end of the study.
Measured: 24 months
Offspring
Proportion of offspring with adequate UIC at 6-12 weeks old.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start14 Oct 2021
- Primary completion21 Jul 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iodine DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Public Health Agency (Northern Ireland), Dairy Council for Northern Ireland
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Karen Mullan, MD, Principal investigator, Belfast Health and Social Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170997
- Sponsor's protocol ID
- B20/32
- Other IDs
- EAT/5578/19
- Status last verified
- Feb 2024
- First submitted
- 25 Nov 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Improve Iodine Status in Early Pregnancy
- ClinicalTrials.gov ID
- NCT05170997
- Acronym / sponsor ID
- B20/32
- Conditions
- Iodine Deficiency, Pregnancy Related
- Keywords
- Iodine, Pregnancy, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Belfast Health and Social Care Trust, Public Health Agency (Northern Ireland), Dairy Council for Northern Ireland
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 28 Dec 2021 (actual)
- 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.
This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.
Detailed description
Women of child bearing age, and those who are currently pregnant, have been found to be iodine deficient in the United Kingdom (UK). Dairy products are an essential source of iodine in the UK as iodised salt is not widely available. This study will ask women in the intervention group to drink approximately one pint of milk a day for 12 weeks during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
| Arm | Type | Receives |
|---|---|---|
| Iodine Control | Active comparator | Other: British Dietetic Association Iodine Fact Sheet.Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. |
| No Iodine Control | Active comparator | Other: British Dietetic Association Iodine Fact Sheet.Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. |
| Iodine Intervention | Experimental | Dietary Supplement: Cows' milk, Other: British Dietetic Association Iodine Fact Sheet.Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. |
| No Iodine Intervention | Experimental | Dietary Supplement: Cows' milk, Other: British Dietetic Association Iodine Fact Sheet.Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- women at 6-16 weeks pregnant
- women receiving antenatal care within Belfast Health and Social Care Trust
Key exclusion criteria (5 listed)
- women with known thyroid disease currently taking thyroid medication
- women with type one diabetes
- women under 18 years of age
- those unable to provide informed consent
- women with abnormal thyroid function tests at booking appointment.
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 |
|---|---|---|
| Cows' milkIntervention groups will receive a free 12 week supply of cows' milk equating to a pint a day for study participants. Milk is provided by Lakeland dairies. | Dietary supplement | Iodine Intervention, No Iodine Intervention |
| British Dietetic Association Iodine Fact Sheet.All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources. | Other | Iodine Control, Iodine Intervention, No Iodine Control, No Iodine Intervention |
Primary outcome
Urinary iodine concentration
Time frame: 18 months
Proportion of the maternal cohort who achieve WHO urinary iodine concentration(UIC) of >=150 micrograms/litre on early morning spot urinary sampling at 12 weeks post intervention.
3 secondary outcomes
Iodine knowledge
Time frame: 24 months
Iodine intake
Time frame: 24 months
Offspring
Time frame: 24 months.
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 7 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Karen Mullan, MD principal investigator
Belfast Health and Social Care Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cows' milk and British Dietetic Association Iodine Fact Sheet. in people with Iodine Deficiency and Pregnancy Related, run by Queen's University, Belfast 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 2 inclusion and 5 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 7 Feb 2024. 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: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.