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Assessment of the Daily Average Requirement of Iodine in Lactating Women

NCT05382793 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-09-03

No results posted yet for this study

Summary

Human milk is the only source of iodine during early infancy and adequate iodine intake during lactation is necessary to assure optimal thyroid function in breastfed infants. However, the physiological requirement of iodine in lactating women is uncertain and recommendations for the daily dietary average requirement are poorly defined. WHO recommends iodine supplementation to lactating women in populations with incomplete coverage of iodized salt and deficient iodine intake, but the scientific evidence is weak and the optimal dose is uncertain.

The primary objective is to assess the daily dietary average requirement for iodine in lactating women.

Secondary objectives are to:

* Estimate the daily average requirement for iodine in exclusively breastfed infants;
* Assess the dose-response of dietary iodine supplements on breast milk iodine concentration in lactating women with adequate and inadequate habitual iodine intakes;
* Estimate the maternal iodine intake required to provide exclusively breastfed infants with an adequate iodine intake via breast milk.

Conditions

  • Healthy
  • Iodine Deficiency

Interventions

DIETARY_SUPPLEMENT

Control

No iodine

DIETARY_SUPPLEMENT

Iodide (150 μg/day)

A single oral tablet once daily for five days providing 150 μg iodine as potassium iodide

DIETARY_SUPPLEMENT

Iodine (300 μg/day)

Two oral tablets (150 μg + 150 μg) daily for five days providing 300 μg iodine as potassium iodide

Sponsors & Collaborators

  • ETH Zurich (Switzerland)

    collaborator OTHER

  • University Children's Hospital, Zurich

    lead OTHER

Principal Investigators

  • Christian Braegger, M.D. · University Children's Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-06
Primary Completion
2023-12-15
Completion
2023-12-15

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05382793 on ClinicalTrials.gov