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Completed

NCT Number: NCT03889431

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hawassa University

Awasa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodine capsule

Dietary Supplement

225 µg of iodine daily as a capsule of potassium iodide

Iodized Salt

Other

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

Primary outcomes

  1. Change from baseline breast milk iodine concentration (µg/L) at six months

    Time frame: First week after delivery and at six months

    Laboratory analysis

  2. Change from baseline urinary iodine concentration (µg/L at six months

    Time frame: First week after delivery and at six months

    Laboratory analysis

  3. Change from baseline Infants' anthropometric measurement (Z-score) at six months

    Time frame: First week after delivery and at six months

    Measurement

Secondary outcomes

  1. Change from baseline thyroid hormones status at six months

    Time frame: First week after delivery and at six months

    Laboratory analysis

  2. Infants' visual information processing

    Time frame: At six months after delivery

    Looking behavior test

Sponsors and collaborators

Lead sponsor

Oklahoma State University

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2019
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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