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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Iodine Deficiency Goiter, Infant Development

Intervention / Treatment
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* Dietary Supplement: Iodine capsule
* Other: Iodized Salt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline breast milk iodine concentration (µg/L) at six months | Laboratory analysis | First week after delivery and at six months | 
| Change from baseline urinary iodine concentration (µg/L at six months | Laboratory analysis | First week after delivery and at six months | 
| Change from baseline Infants' anthropometric measurement (Z-score) 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 | Laboratory analysis | First week after delivery and at six months | 
| Infants' visual information processing | Looking behavior test | At six months after delivery |