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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03889431
Enrollment
106
Registered
2019-03-26
Start date
2013-01-02
Completion date
2013-08-10
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development, Iodine Deficiency Goiter

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.

Interventions

DIETARY_SUPPLEMENTIodine capsule

225 µg of iodine daily as a capsule of potassium iodide

450 g iodized salt provided for the household weekly. Salt iodine content was 30 to 40 mg iodine /kg salt as KIO3

Sponsors

Oklahoma State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline breast milk iodine concentration (µg/L) at six monthsFirst week after delivery and at six monthsLaboratory analysis
Change from baseline urinary iodine concentration (µg/L at six monthsFirst week after delivery and at six monthsLaboratory analysis
Change from baseline Infants' anthropometric measurement (Z-score) at six monthsFirst week after delivery and at six monthsMeasurement

Secondary

MeasureTime frameDescription
Change from baseline thyroid hormones status at six monthsFirst week after delivery and at six monthsLaboratory analysis
Infants' visual information processingAt six months after deliveryLooking behavior test

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026