Iodine Deficiency, Pregnancy Related
Conditions
Keywords
Iodine, Pregnancy, Diet
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCows' milk
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.
OTHERBritish 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.
Sponsors
Belfast Health and Social Care Trust
Public Health Agency (Northern Ireland)
Dairy Council for Northern Ireland
Queen's University, Belfast
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary iodine concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iodine knowledge | 24 months | 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. |
| Iodine intake | 24 months | 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. |
| Offspring | 24 months. | Proportion of offspring with adequate UIC at 6-12 weeks old. |
Countries
United Kingdom
Outcome results
None listed