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
  Purpose

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.


Condition Intervention
Iodine Deficiency
Dietary Supplement: Iodized oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Iodized Oil Supplementation During Infancy

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Infant height and weight [ Time Frame: 1st year after birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 241
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iodized oil to mother
400 mg iodine as iodized oil to breastfeeding mother
Dietary Supplement: Iodized oil
400 mg of iodine vs 100 mg of iodine as iodized oil
Active Comparator: Iodized oil to infant
100 mg of iodine as iodized oil to infant
Dietary Supplement: Iodized oil
400 mg of iodine vs 100 mg of iodine as iodized oil

Detailed Description:

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).
  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breastfeeding term infant

Exclusion Criteria:

  • not breastfeeding
  • major medical illnesses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126125

Locations
Morocco
Semilila Faculty of Sciences
Marrakech, Morocco
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Michael B Zimmermann, MD Swiss Federal Institute of Technology Zurich
  More Information

No publications provided by Swiss Federal Institute of Technology

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01126125     History of Changes
Other Study ID Numbers: SwissFIT
Study First Received: May 17, 2010
Last Updated: November 7, 2012
Health Authority: Morocco: Ministry of Public Health

Keywords provided by Swiss Federal Institute of Technology:
iodine
infant
breastfeeding
deficiency

Additional relevant MeSH terms:
Iodized Oil
Contrast Media
Diagnostic Uses of Chemicals
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014