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

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

Interventions

DIETARY_SUPPLEMENT

iodine

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

DIETARY_SUPPLEMENT

Placebo

Patients are given a non-iodine containing multivitamin tablet

Sponsors & Collaborators

• Sahlgrenska University Hospital

  collaborator OTHER

• Göteborg University

  lead OTHER

Principal Investigators

• Helena Filipsson Nyström, Ass Prof · Center for Endocrinology and Metabolism, SAhlgrenska University Hospital, göteborg, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2017-12-31

Completion

2024-03-05

Countries

• Sweden

Study Locations