Strategies to Improve Iodine Status in Early Pregnancy

Study Overview
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Brief Summary
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This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.

Detailed Description
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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.

Official Title
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Strategies to Improve Iodine Status in Early Pregnancy

Conditions
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Iodine Deficiency, Pregnancy Related

Intervention / Treatment
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* Dietary Supplement: Cows' milk
* Other: British Dietetic Association Iodine Fact Sheet.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women at 6-16 weeks pregnant women receiving antenatal care within Belfast Health and Social Care Trust Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iodine Control<br>Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. | Other: British Dietetic Association Iodine Fact Sheet.<br>* All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.<br>|
| Active Comparator: No Iodine Control<br>Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. | Other: British Dietetic Association Iodine Fact Sheet.<br>* All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.<br>|
| Experimental: Iodine Intervention<br>Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. | Dietary Supplement: Cows' milk<br>* 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.<br>Other: British Dietetic Association Iodine Fact Sheet.<br>* All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.<br>|
| Experimental: No Iodine Intervention<br>Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. | Dietary Supplement: Cows' milk<br>* 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.<br>Other: British Dietetic Association Iodine Fact Sheet.<br>* All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 24 months | 
| Offspring | Proportion of offspring with adequate UIC at 6-12 weeks old. | 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iodine, Pregnancy, Diet