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| ID | Type | Description | Link |
|---|---|---|---|
| EAT/5578/19 | Other Grant/Funding Number | Public Health Agency R&D fellowship |
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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| Public Health Agency (Northern Ireland) | UNKNOWN |
| Dairy Council for Northern Ireland | OTHER |
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This study aims to investigate the benefit of increased intake of cows' milk during pregnancy on iodine status.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iodine Control | Active Comparator | Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. |
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| No Iodine Control | Active Comparator | Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply. |
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| Iodine Intervention | Experimental | Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. |
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| No Iodine Intervention | Experimental | Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cows' milk | Dietary 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Mullan, MD | Belfast Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Jubilee Maternity Hospital | Belfast | BT12 6BA | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2021 | Dec 9, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 6, 2021 | Dec 9, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008892 | Milk |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
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There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
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| 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. |
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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. |
| D005502 |
| Food |
| D019602 | Food and Beverages |