Study of the Effect of Iodized Oil Supplementation During Infancy (INSIGHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01126125
First received: May 17, 2010
Last updated: November 7, 2012
Last verified: November 2012

May 17, 2010
November 7, 2012
May 2010
August 2012   (final data collection date for primary outcome measure)
Infant height and weight [ Time Frame: 1st year after birth ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01126125 on ClinicalTrials.gov Archive Site
  • Infant head circumference [ Time Frame: 1st year after birth ] [ Designated as safety issue: No ]
  • Thyroid hormone concentrations [ Time Frame: 1st year after birth ] [ Designated as safety issue: Yes ]
  • Urinary iodine concentrations [ Time Frame: 1st year after birth ] [ Designated as safety issue: No ]
  • Infant development score [ Time Frame: 1st year after birth ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Effect of Iodized Oil Supplementation During Infancy
Iodized Oil Supplementation During Infancy

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.

In iodine-deficient countries or regions that have inadequate iodized salt distribution, WHO recommends choosing one of two methods to improve iodine intakes in breastfeeding infants:

Method 1) iodine supplement (400 mg as iodized oil; 1/year) to the breastfeeding mother Method 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.

The mountains of southern Morocco are areas of iodine deficiency. Although the government has been promoting iodization of salt, there are hundreds of small salt producers in the mountains who do not have the funding or infrastructure to iodize their salt, and thus many rural populations still are consuming non-iodized locally-produced salt. At the study site, a 2009 pilot survey of urinary iodine has found that the population in this region is moderately iodine sufficient.

Thus, according to WHO, breastfeeding women and/or their infants should be provided with oral iodine supplementation. But which of the above supplementation methods is preferable? Controlled studies clearly demonstrate that iodine repletion in moderate-to severely iodine deficient school-age children increases insulin-like growth factor (IGF)-1 and insulin-like growth factor binding protein (IGFBP)-3 concentrations and improves somatic growth (height and weight). But whether supplying adequate iodine to iodine deficient infants improves their somatic growth has not been tested.

Therefore, the study hypotheses are: In Moroccan infants who are breastfeeding, method 2 will be more efficacious than method 1 in:

  1. increasing urinary iodine (UI) concentrations
  2. improving thyroid function (TSH, TT4)
  3. increasing IGF-1, IGFBP-3
  4. improving somatic growth (length, weight, head circumference)

The study design will be a double-blind, randomized controlled intervention trial in southern Morocco lasting 1 year. Healthy mother-infant pairs (n=240) who are breastfeeding will be recruited while the infant is >1 mo of age. They will be divided into two groups as follows:

1) method 1: mother receives 400 mg of iodine as oral iodized oil + infant receives placebo capsule; or 2) method 2: mother receives placebo capsule + infant receives 100 mg oral iodized oil.

The outcomes will be:

  1. length, weight, head circumference
  2. IGF-1, IGFBP-3, thyroid functions (TSH, total T4) from a dried blood spot taken from a finger prick in the mothers/heel prick in the infants
  3. urinary and breast milk iodine concentrations These samples (blood spot, urine, breastmilk, anthropometry) will be collected during the first year visits of the infant to the local health clinic for routine pediatric vaccinations (at 1, 12, 20 and 40-52 wks).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Iodine Deficiency
Dietary Supplement: Iodized oil
400 mg of iodine vs 100 mg of iodine as iodized oil
  • Experimental: Iodized oil to mother
    400 mg iodine as iodized oil to breastfeeding mother
    Intervention: Dietary Supplement: Iodized oil
  • Active Comparator: Iodized oil to infant
    100 mg of iodine as iodized oil to infant
    Intervention: Dietary Supplement: Iodized oil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
241
August 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • breastfeeding term infant

Exclusion Criteria:

  • not breastfeeding
  • major medical illnesses
Both
up to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Morocco
 
NCT01126125
SwissFIT
Yes
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Not Provided
Principal Investigator: Michael B Zimmermann, MD Swiss Federal Institute of Technology Zurich
Swiss Federal Institute of Technology
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP