Breast milk and Iodine Study

A randomised double-blind, placebo-controlled intervention trial to study the effect of iodine supplementation on breast milk iodine concentration and iodine status in lactating women and their breast-fed infants

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000345684

Enrollment

106

Registered

2005-09-09

Start date

2004-05-01

Completion date

2005-10-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

New Zealand has low soil iodine and the NZ diet can be low in iodine. Breastfeeding women need to get enough iodine in their diet so that they make milk with sufficient levels of iodine. This study will measure the amount of iodine in breastmilk in women who are taking a placebo (i.e. Is there enough iodine in the diet of breastfeeding NZ women now?) or iodine containing supplement (i.e. If not, will more iodine in the diet make the iodine levels in their breastmilk increase?).

Interventions

Random allocation of placebo, iodine (75 micrograms/day), or iodine (150 micrograms/day) supplements to lactating women for the first six months of lactation.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Commitment to six months of breast-feeding.

Exclusion criteria

No known thyroid disease. Not taking iodine containing dietary supplements. Singleton birth. Premature (<38 weeks) birth.

Outcome results