Strategies to Improve Iodine Status in Early Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Iodine Deficiency
• Intervention / Treatment: Other: British Dietetic Association Iodine Fact Sheet.; Dietary supplement: Cows' milk

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Jubilee Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Iodine Control; Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply.	Other: 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.
Active Comparator: No Iodine Control; Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply.	Other: 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.
Experimental: Iodine Intervention; Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.	Other: 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.; Dietary supplement: Cows' 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.
Experimental: No Iodine Intervention; Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.	Other: 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.; Dietary supplement: Cows' 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: Belfast Health and Social Care Trust; Public Health Agency (Northern Ireland); Dairy Council for Northern Ireland
• Investigators: Principal Investigator: Karen Mullan, MD, Belfast Health and Social Care Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): August 3, 2023

Study Registration Dates

• First Submitted: November 25, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Iodine; Pregnancy; Diet
• Other Study ID Numbers: B20/32; EAT/5578/19 (Other Grant/Funding Number: Public Health Agency R&D fellowship)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No