NCT02045784

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2.3 years

First QC Date

January 22, 2014

Last Update Submit

November 7, 2017

Conditions

Focus: Establish the Iodine Requirement During Infancy

Outcome Measures

Primary Outcomes (1)

  • Iodine retention

    The amount of iodine retained will be calculated as the difference between measured iodine intake and measured iodine excretion

    4 days

Study Arms (4)

Infant formula milk 60 µg iodine/day

EXPERIMENTAL

Infant formula containing 57 µg/100 g powder, providing approximately 60 µg iodine/day (i.e. 55% of the current AI). Unrestricted consumption during 11 days.

Dietary Supplement: Infant formula

Infant formula milk 110 µg iodine/day

EXPERIMENTAL

Infant formula containing 92 µg/100 g powder, providing approximately 110 µg iodine/day (i.e. 100% of the current AI). Unrestricted consumption during 11 days.

Dietary Supplement: Infant formula

Infant formula 220 µg iodine/day

EXPERIMENTAL

Infant formula containing 217 µg/100 g powder, providing approximately 220 µg iodine/day (i.e. 200% of the current AI). Unrestricted consumption during 11 days.

Dietary Supplement: Infant formula

Breast milk

OTHER

Unrestricted consumption during 4 days

Other: Breast milk

Interventions

Infant formulaDIETARY_SUPPLEMENT

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.

Infant formula 220 µg iodine/dayInfant formula milk 110 µg iodine/dayInfant formula milk 60 µg iodine/day
Breast milkOTHER

Unlimited breast feeding

Breast milk

Eligibility Criteria

Age5 Weeks - 14 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy mother/infant pairs (considering the following criteria: normal thyroid function, adequate iron status, no apparent infection)
  • Full term birth (in week 38 to 42), birth weight \>2 500 g, singleton birth
  • No known family history of thyroid disease
  • Infant does not have persistent stomach and/or intestine symptoms
  • Mother did not use: a) X-ray or CT contrast agent (both may contain iodine); b) iodine containing medication within the last year
  • Formula fed infants study arm: Infant is fully formula fed and was already formula fed prior to the study
  • Formula fed infants study arm: Infant was fed with formula based on cow's milk protein prior to the study
  • Formula fed infants study arm: Infant shows no signs of cow's milk allergy
  • Breast fed infants study arm: Infant is fully breast fed and was fully breast fed prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North-West University South Africa

Potchefstroom, 2520, South Africa

Location

ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

  • Dold S, Zimmermann MB, Baumgartner J, Davaz T, Galetti V, Braegger C, Andersson M. A dose-response crossover iodine balance study to determine iodine requirements in early infancy. Am J Clin Nutr. 2016 Sep;104(3):620-8. doi: 10.3945/ajcn.116.134049. Epub 2016 Jul 27.

    PMID: 27465383DERIVED

MeSH Terms

Interventions

Infant FormulaMilk, Human

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and BeveragesMilkDairy Products

Study Officials

  • Maria Andersson, PhD

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 27, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

ZA(1)CH(1)