Strategies to Improve Iodine Status in Early Pregnancy

NCT05170997 | Completed

• 2 other identifiers: B20/32EAT/5578/19
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iodine Deficiency; Pregnancy Related

Keywords

Iodine; Pregnancy; Diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Iodine knowledge

  24 months

• Iodine intake

  24 months

• Offspring

  24 months.

Study Arms (4)

Iodine Control

ACTIVE COMPARATOR

Participants taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply.

Other: British Dietetic Association Iodine Fact Sheet.

No Iodine Control

ACTIVE COMPARATOR

Participants not taking an iodine-containing multivitamin or supplement and randomly allocated not to receive milk supply.

Other: British Dietetic Association Iodine Fact Sheet.

Iodine Intervention

EXPERIMENTAL

Participants taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.

Dietary Supplement: Cows' milk; Other: British Dietetic Association Iodine Fact Sheet.

No Iodine Intervention

EXPERIMENTAL

Participants not taking an iodine-containing multivitamin or supplement and randomly allocated to receive milk supply.

Dietary Supplement: Cows' milk; Other: British Dietetic Association Iodine Fact Sheet.

Interventions

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.

Iodine Intervention; No Iodine Intervention

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.

Iodine Control; Iodine Intervention; No Iodine Control; No Iodine Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women at 6-16 weeks pregnant
• women receiving antenatal care within Belfast Health and Social Care Trust

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator
• Public Health Agency (Northern Ireland): collaborator
• Dairy Council for Northern Ireland: collaborator

Study Sites (1)

Royal Jubilee Maternity Hospital

Belfast, BT12 6BA, United Kingdom

Location

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Karen Mullan, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 28, 2021
• Study Start: October 14, 2021
• Primary Completion: July 21, 2023
• Study Completion: August 3, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)