Strategies to Improve Iodine Status in Early Pregnancy

NCT ID: NCT05170997

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2023-08-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Iodine Deficiency Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There will be four parallel groups in this study, stratified by iodine supplementation and then randomised to milk or control group.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Iodine Control

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

Group Type ACTIVE_COMPARATOR

British Dietetic Association Iodine Fact Sheet.

Intervention Type OTHER

All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.

No Iodine Control

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

Group Type ACTIVE_COMPARATOR

British Dietetic Association Iodine Fact Sheet.

Intervention Type OTHER

All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.

Iodine Intervention

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

Group Type EXPERIMENTAL

Cows' milk

Intervention Type 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.

British Dietetic Association Iodine Fact Sheet.

Intervention Type OTHER

All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.

No Iodine Intervention

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

Group Type EXPERIMENTAL

Cows' milk

Intervention Type 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.

British Dietetic Association Iodine Fact Sheet.

Intervention Type OTHER

All participants will receive the British Dietetic Association Iodine fact sheet which discusses the importance of iodine and the dietary sources.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role collaborator

Public Health Agency (Northern Ireland)

UNKNOWN

Sponsor Role collaborator

Dairy Council for Northern Ireland

OTHER

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

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Jayne Woodside, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Mullan, MD

Role: PRINCIPAL_INVESTIGATOR

Belfast Health and Social Care Trust

Locations

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Royal Jubilee Maternity Hospital

Belfast, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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EAT/5578/19

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

B20/32

Identifier Type: -

Identifier Source: org_study_id

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