Iodine Status in Swedish Lactating Women - Effect of Iodine Supplementation in the Thyroid Function of Mother and Infant

NCT02378233 | Terminated

• 1 other identifier: 12012002
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to measure urinary milk iodine concentration (MIC), iodine concentration (UIC), thyroid hormones (TSH, FT4) and thyroperoxidase antibodies (TPOab) in breast-feeding women, and UIC in their nursing infants to determine if the levels are adequate, and to see how they can be influenced by 150 ug daily iodine supplementation in breast-feeding women. The hypothesis is that there is a relative iodine deficiency in this sub-population - lactating women and nursing children-, and that this can be influenced by iodine supplementation. Adequate thyroid hormone and iodine levels are very important for small children, when the plasticity of the brain is greatest. This is as a prospective, double-blind, placebo-controlled study of 221 mothers and their infants. In parallel, 90 age-matched healthy non-pregnant women are recruited. Mothers are randomized to 150 µg/day iodide supplementation or placebo. Pregnant women are asked for participation on a visit in pregnancy week 37, at the mother health care (MVC) at Mölnlycke and Skövde. The study will run for approximately 3 months for each individual and begins by sampling A (UIC, TSH, FT4, TPOab) at week 37 of the pregnancy, when mothers also get randomized to 150 µg iodine or placebo. New sampling B (UIC, TSH, FT4, MIC ) is collected when the baby is 3 months old. Thereafter the study is completed. In parallel, 90 healthy non-pregnant, non-lactating women in the same age range are recruited and followed with UIC, TSH, FT4, TPOab for 6 months as a control group. In each case a simple questionnaire is filled and blood is also frozen for future analyses.

Conditions

Thyroid Gland; Node; Lactation

Keywords

Iodine; Double-Blind Method; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• milk iodine concentration

  3 months after birth (within 7 days)

• urinary iodine concentration in the infant

  3 months after birth (within 7 days)

Secondary Outcomes (8)

• TSH in the mother

  pregnancy week 37

• TSH in the mother

  3 months after birth

• FT4 in the mother

  pregnancy week 37

• FT4 in the mother

  3 months after birth

• TPOab in the mother

  pregnancy week 37

Study Arms (2)

iodine

EXPERIMENTAL

iodine containing multivitamin 150 ug, 1 tablet daily

Dietary Supplement: iodine

placebo

PLACEBO COMPARATOR

placebo, 1 tablet Daily of a non-iodine containing multivitamin

Dietary Supplement: Placebo

Interventions

iodine DIETARY_SUPPLEMENT

The intervention is to give a multivitamin pill including 150 microgram iodine and compare with a multivitamin pill that is not including iodine.

iodine

Placebo DIETARY_SUPPLEMENT

Patients are given a non-iodine containing multivitamin tablet

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years.
• Pregnancy longer than week 36.
• Single Pregnancy.
• Planned breastfeeding.
• No current thyroid disease.
• Agree not to take iodine supplementation except as provided through the study.

You may not qualify if:

• Patient who is not expected to adhere to the research protocol. Plans for pregnancy within 6 months after delivery.
• Vegans.
• CONTROL WOMAN:
• years.
• No current thyroid disease.
• Agree not to iodine supplementation during the study.
• Patient who is not expected to adhere to the research protocol.
• Plans for pregnancy within 6 months of study entry.
• Vegans.

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Health Care center

Mölnlycke, SE-435 30, Sweden

Location

MeSH Terms

Conditions

Thyroid Diseases; Breast Feeding

Interventions

Iodine

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals

Study Officials

• Helena Filipsson Nyström, Ass Prof

  Center for Endocrinology and Metabolism, SAhlgrenska University Hospital, göteborg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: March 4, 2015
• Study Start: October 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: March 5, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

SE (1)