Strategies to Improve Iodine Status in Early Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related; Iodine Deficiency
• Interventions: Other: British Dietetic Association Iodine Fact Sheet.; Dietary Supplement: Cows' milk

• Registration Number: NCT05170997
• Lead Sponsor: Queen's University, Belfast

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.

Study Timeline

• Study Start: 2021-10-14
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-28
• Primary Completion: 2023-07-21
• Study Completion: 2023-08-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodine Control	British Dietetic Association Iodine Fact Sheet.	Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply.
Iodine Intervention	British Dietetic Association Iodine Fact Sheet.	Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.
No Iodine Control	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	Cows' milk	Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.
No Iodine Intervention	Cows' milk	Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.
No Iodine Intervention	British Dietetic Association Iodine Fact Sheet.	Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Royal Jubilee Maternity Hospital; 🇬🇧 Belfast, United Kingdom