Study of the Effect of Iodized Oil Supplementation During Infancy
INSIGHT
Iodized Oil Supplementation During Infancy
1 other identifier
interventional
241
1 country
1
Brief Summary
In iodine-deficient countries or regions that have inadequate iodized salt distribution, the World Health Organization (WHO) recommends choosing one of two methods to improve iodine intakes in breastfeeding infants: 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother, or 2) iodine supplement (100 mg as iodized oil; 1/year) directly to the infant. However, the relative efficacy of these two methods of providing iodine to the newborn has never been directly compared. Whether the first method of iodine supplementation to the breast feeding mother can significantly improve iodine supply and maintain normal thyroid function in her infant remains unclear. This study will directly compare these two strategies. The hypothesis is that the two strategies will be equally effective in providing iodine to the newborn.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedNovember 8, 2012
November 1, 2012
2.3 years
May 17, 2010
November 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infant height and weight
1st year after birth
Secondary Outcomes (4)
Infant head circumference
1st year after birth
Thyroid hormone concentrations
1st year after birth
Urinary iodine concentrations
1st year after birth
Infant development score
1st year after birth
Study Arms (2)
Iodized oil to mother
EXPERIMENTAL400 mg iodine as iodized oil to breastfeeding mother
Iodized oil to infant
ACTIVE COMPARATOR100 mg of iodine as iodized oil to infant
Interventions
400 mg of iodine vs 100 mg of iodine as iodized oil
Eligibility Criteria
You may qualify if:
- breastfeeding term infant
You may not qualify if:
- not breastfeeding
- major medical illnesses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Semilila Faculty of Sciences
Marrakesh, Marrakech, Morocco
Related Publications (1)
Bouhouch RR, Bouhouch S, Cherkaoui M, Aboussad A, Stinca S, Haldimann M, Andersson M, Zimmermann MB. Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 Mar;2(3):197-209. doi: 10.1016/S2213-8587(13)70155-4. Epub 2013 Nov 22.
PMID: 24622750DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael B Zimmermann, MD
Swiss Federal Institute of Technology Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 19, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
November 8, 2012
Record last verified: 2012-11