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

Not Applicable

Completed

• Conditions: Iodine Deficiency Goiter; Infant Development
• Interventions: Other: Iodized Salt; Dietary Supplement: Iodine capsule

• Registration Number: NCT03889431
• Lead Sponsor: Oklahoma State University

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.

Study Timeline

• Study Start: 2013-01-02
• Primary Completion: 2013-01-30
• Study Completion: 2013-08-10
• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-21
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodized salt group	Iodized Salt	Group two received iodized salt
Capsule group	Iodine capsule	Group one received iodine capsule

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline thyroid hormones status at six months	First week after delivery and at six months	Laboratory analysis
Infants' visual information processing	At six months after delivery	Looking behavior test

Trial Locations

Locations (1)

Hawassa University; 🇪🇹 Hawassa, Ethiopia