Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants

March 21, 2019 updated by: Barbara Stoecker, Oklahoma State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
      • Hawassa, Ethiopia
        • Hawassa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsule group
Group one received iodine capsule
Dietary supplement: Iodine capsule
225 µg of iodine daily as a capsule of potassium iodide
Experimental: Iodized salt group
Group two received iodized salt
Other: Iodized Salt
450 g iodized salt provided for the household weekly. Salt iodine content was 30 to 40 mg iodine /kg salt as KIO3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline breast milk iodine concentration (µg/L) at six months
Time Frame: First week after delivery and at six months
Laboratory analysis
First week after delivery and at six months
Change from baseline urinary iodine concentration (µg/L at six months
Time Frame: First week after delivery and at six months
Laboratory analysis
First week after delivery and at six months
Change from baseline Infants' anthropometric measurement (Z-score) at six months
Time Frame: First week after delivery and at six months
Measurement
First week after delivery and at six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline thyroid hormones status at six months
Time Frame: First week after delivery and at six months
Laboratory analysis
First week after delivery and at six months
Infants' visual information processing
Time Frame: At six months after delivery
Looking behavior test
At six months after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oklahoma State University

Investigators

  • Principal Investigator: Tafere Gebreegziabher, PhD, Central Washington University & Hawassa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2013

Primary Completion (Actual)

January 30, 2013

Study Completion (Actual)

August 10, 2013

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE1156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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