Assessment of the Daily Average Requirement of Iodine in Lactating Women

NCT ID: NCT05382793

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2023-12-15

Brief 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.

Detailed Description

This study is a single center, randomized, controlled, dose-response metabolic balance study with cross-over design. The study will be conducted in 24 exclusively breastfeeding women and their infants receding in Zürich, Switzerland. The study involves an initial screening, a 2 weeks run-in period and a balance period over 3 weeks. Participating women will be allocated to two groups based on their consumption of dietary iodine supplements during pregnancy. Women who consumed daily iodine supplements during pregnancy will be assigned to group 1 (n=12) and receive daily supplements containing 150 µg iodine for 2 weeks, whereas women who did not will be enrolled in group 2 and will receive no supplement during the run-in period. Breast milk and spot urine samples (mothers and infants) will be collected daily in all participants during two weeks for the measurement of breast milk and urinary iodine concentrations. During the balance period, all women will receive either no supplement, iodine supplements providing 150 µg/day, or 300 µg/day in random order with cross-over design. Each supplement dose will be assessed in a test period of 7 days, including 2 run-in days, 3 balance days and 2 wash-out days. The supplements will be consumed during the first 5 days in each test-period. During the 3 balance days, the daily iodine intake and excretion will be measured in mothers and infants, and the iodine retention will be calculated for each regimen and study group. The minimum daily average requirement will be determined as the iodine intake where the iodine retention is zero.

Conditions

Healthy; Iodine Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lactating women with assumed adequate habitual iodine intake

Women who consumed iodine-containing dietary supplements during pregnancy (≥150 μg/day). Women in this group will receive a daily oral iodine supplement providing 150 μg iodine as potassium iodide for 14 days before the study start.

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

No iodine

Iodide (150 μg/day)

Intervention Type: DIETARY_SUPPLEMENT

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

Iodine (300 μg/day)

Intervention Type: DIETARY_SUPPLEMENT

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

Lactating mothers with assumed inadequate habitual iodine intake

Women who did not consume iodine-containing dietary supplements during pregnancy (≥150 μg/day).

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

No iodine

Iodide (150 μg/day)

Intervention Type: DIETARY_SUPPLEMENT

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

Iodine (300 μg/day)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Control

No iodine

Intervention Type: DIETARY_SUPPLEMENT

Iodide (150 μg/day)

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

Intervention Type: DIETARY_SUPPLEMENT

Iodine (300 μg/day)

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, Germany; Jodetten® 150 Henning, Sanofi-Aventis Germany GmbH, Germany

Eligibility Criteria

Inclusion Criteria

1. Consent to enroll herself and her baby;

2. Age 18 to 49 years;

3. Singleton pregnancy;

4. Exclusively breastfeeding;

5. Self-estimated BMI <30 kg/m2 before conception.

1. Full term (38-42 weeks);

2. Birthweight ≥2.5 kg;

3. Exclusively breastfed;

4. Age 0-10 weeks at recruitment.

Exclusion Criteria

1. TSH >6 mIU/L;

2. Anemia (Hb <11.7 g/L);

3. Pregnancy (self-reported);

4. Acute illness (e.g. gastroenteritis);

5. History of thyroid disease, diabetes, metabolic disease or inflammatory bowel disease (self-reported);

6. Currently smoking (>1 cigarette/day);

7. Drug abuse or extensive alcohol intake;

8. Exposure to iodine-containing X-ray or computed tomography contrast agents during the past 6 months;

9. Adenomatous goiter, dermatitis, anti-C1q-vasculitis.

Infants

1. Age >6 months;

2. TSH >10 mIU/L at neonatal screening at 2-5 days after birth (i.e. infants not requested to attend recall assessment);

3. Diagnosed or suspected colic.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ETH Zurich (Switzerland)

OTHER

Sponsor Role: collaborator

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Braegger, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital, Zurich

Locations

Nutrition Research Unit, University Children's Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

BASEC2022-00130

Identifier Type: -

Identifier Source: org_study_id