Clinical trial NCT03889431: 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
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Deficiency Goiter
Infant Development
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline breast milk iodine concentration (µg/L) at six months
timeFrame: First week after delivery and at six months
measure: Change from baseline urinary iodine concentration (µg/L at six months
timeFrame: First week after delivery and at six months
measure: Change from baseline Infants' anthropometric measurement (Z-score) at six months
timeFrame: First week after delivery and at six months
Secondary outcomes:
measure: Change from baseline thyroid hormones status at six months
timeFrame: First week after delivery and at six months
measure: Infants' visual information processing
timeFrame: At six months after delivery
Other outcomes:
Locations:
city: Hawassa
country: Ethiopia
facility: Hawassa University
Study officials:
affiliation: Central Washington University & Hawassa University
name: Tafere Gebreegziabher, PhD
role: PRINCIPAL_INVESTIGATOR
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