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OpenTrials
Completed

NCT Number: NCT05170997

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.

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Key information

Conditions

Iodine Deficiency Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Jubilee Maternity Hospital

Belfast, BT12 6BA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Urinary iodine concentration

    Time frame: 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 outcomes

  1. Iodine knowledge

    Time frame: 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.

  2. Iodine intake

    Time frame: 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.

  3. Offspring

    Time frame: 24 months.

    Proportion of offspring with adequate UIC at 6-12 weeks old.

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Belfast Health and Social Care Trust
  • Dairy Council for Northern Ireland
  • Public Health Agency (Northern Ireland)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 28, 2021
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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