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Establishing the Iodine Requirement in Infancy

NCT02045784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-11-08

No results posted yet for this study

Summary

The objective of this study is to define the amount of dietary iodine needed per day during the first six months of life. The hypothesis is that the current recommended iodine intake in infants is set too high.

Conditions

  • Focus: Establish the Iodine Requirement During Infancy

Interventions

DIETARY_SUPPLEMENT

Infant formula

To establish dose-response relationships, formula-fed infants will be randomly allocated to three 11-day cross-over periods of exclusive consumption of infant formula providing different amounts of iodine. All iodine levels are within the required iodine levels for infant formula following the regulations of the United States, the European Union, Switzerland and New Zealand.

OTHER

Breast milk

Unlimited breast feeding

Sponsors & Collaborators

  • North-West University, South Africa

    collaborator OTHER

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Maria Andersson, PhD · ETH Zurich

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
5 Weeks
Max Age
14 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • South Africa
  • 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 NCT02045784 on ClinicalTrials.gov