Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
Primary Purpose
Iodine Deficiency Goiter, Infant Development
Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Iodine capsule
Iodized Salt
Sponsored by
About this trial
This is an interventional treatment trial for Iodine Deficiency Goiter
Eligibility Criteria
Inclusion Criteria:
- The women must be lactating and must have an infant less than or equal to one week old.
- Mothers had to volunteer to participate in the study.
Exclusion Criteria:
- Any hyperthyroidism symptoms manifested by nervousness, anxiety, heart palpitations, or rapid pulse.
- If infants had fever, cough or severe (>3/day) diarrhea
- Any allergic reaction such as acne, weakness, or foul breath
Sites / Locations
- Hawassa University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Capsule group
Iodized salt group
Arm Description
Group one received iodine capsule
Group two received iodized salt
Outcomes
Primary Outcome Measures
Change from baseline breast milk iodine concentration (µg/L) at six months
Laboratory analysis
Change from baseline urinary iodine concentration (µg/L at six months
Laboratory analysis
Change from baseline Infants' anthropometric measurement (Z-score) at six months
Measurement
Secondary Outcome Measures
Change from baseline thyroid hormones status at six months
Laboratory analysis
Infants' visual information processing
Looking behavior test
Full Information
NCT ID
NCT03889431
First Posted
March 20, 2019
Last Updated
March 21, 2019
Sponsor
Oklahoma State University
1. Study Identification
Unique Protocol Identification Number
NCT03889431
Brief Title
Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
Official Title
Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2013 (Actual)
Primary Completion Date
January 30, 2013 (Actual)
Study Completion Date
August 10, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluated efficacy of iodized salt for mothers and their six-month-old infants' thyroid hormones and visual information processing. Half of the participants received 450 g iodized salt for the household each week, while the other half received 225 ug iodine daily as a potassium iodide capsule.
Detailed Description
Iodine is essential for the synthesis of thyroid hormones, and thyroid hormones regulate the metabolic processes of most cells and play important roles in human growth and development. Iodine deficiency disorders can have serious consequences on brain and physical development. In neonates iodine deficiency and hence insufficient supply of thyroid hormones could cause neonatal goiter, neonatal hypothyroidism, and endemic mental retardation.
Iodine deficiency disorders can be prevented and controlled by providing iodine and iodine can be provided in different ways. However, the United Nations Children's Fund and the World Health Organization jointly recommended salt iodization where iodized salt is accessible. Iodized salt is a safe, cost effective and sustainable strategy to ensure sufficient intake of iodine by all individuals and to improve maternal and infant health. However, although the effect of iodine on human health is well established efficacy of iodized salt has not been studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iodine Deficiency Goiter, Infant Development
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The mother-child dyads were randomly assigned either to receive iodine capsule (n = 53) or iodized salt (n = 53). The iodine capsule group received 225 µg of iodine daily as potassium iodide for 6 months.The iodized salt group was provided with iodized salt (30 to 40 mg iodine/kg as KIO3). One packet of salt (450 g) per household was provided starting within one week of delivery for 6 months.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Capsule group
Arm Type
Experimental
Arm Description
Group one received iodine capsule
Arm Title
Iodized salt group
Arm Type
Experimental
Arm Description
Group two received iodized salt
Intervention Type
Dietary Supplement
Intervention Name(s)
Iodine capsule
Intervention Description
225 µg of iodine daily as a capsule of potassium iodide
Intervention Type
Other
Intervention Name(s)
Iodized Salt
Intervention Description
450 g iodized salt provided for the household weekly. Salt iodine content was 30 to 40 mg iodine /kg salt as KIO3
Primary Outcome Measure Information:
Title
Change from baseline breast milk iodine concentration (µg/L) at six months
Description
Laboratory analysis
Time Frame
First week after delivery and at six months
Title
Change from baseline urinary iodine concentration (µg/L at six months
Description
Laboratory analysis
Time Frame
First week after delivery and at six months
Title
Change from baseline Infants' anthropometric measurement (Z-score) at six months
Description
Measurement
Time Frame
First week after delivery and at six months
Secondary Outcome Measure Information:
Title
Change from baseline thyroid hormones status at six months
Description
Laboratory analysis
Time Frame
First week after delivery and at six months
Title
Infants' visual information processing
Description
Looking behavior test
Time Frame
At six months after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The women must be lactating and must have an infant less than or equal to one week old.
Mothers had to volunteer to participate in the study.
Exclusion Criteria:
Any hyperthyroidism symptoms manifested by nervousness, anxiety, heart palpitations, or rapid pulse.
If infants had fever, cough or severe (>3/day) diarrhea
Any allergic reaction such as acne, weakness, or foul breath
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tafere Gebreegziabher, PhD
Organizational Affiliation
Central Washington University & Hawassa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawassa University
City
Hawassa
Country
Ethiopia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants
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