Strategies to Improve Iodine Status in Early Pregnancy

Pregnancy Related Clinical Trial

Official title:

Strategies to Improve Iodine Status in Early Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170997
• Other study ID #: B20/32
• Secondary ID: EAT/5578/19
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: August 3, 2023

Study information

• Verified date: February 2024
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 3, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Iodine Deficiency
• Pregnancy Related

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	Royal Jubilee Maternity Hospital	Belfast

Sponsors (4)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust, Dairy Council for Northern Ireland, Public Health Agency (Northern Ireland)

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Offspring	Proportion of offspring with adequate UIC at 6-12 weeks old.	24 months.