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CompletedNCT03889431Updated Mar 26, 2019

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

An interventional study of Iodine capsule and Iodized Salt in Iodine Deficiency Goiter and Infant Development, sponsored by Oklahoma State University. Completed at 1 site in Ethiopia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-26.

Sponsored by Oklahoma State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 2 months after the study started (first participant enrolled Jan 2013, registered Mar 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Iodine Deficiency Goiter
  • Infant Development

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03

In context

Goiter

66 studies on the registry are indexed under Goiter; 11 are open to participants now.

This study's enrollment of 106 is close to the median of 100 across 42 interventional studies indexed under Goiter.

Browse Goiter studies →

Lead sponsor

Oklahoma State University is the lead sponsor of 39 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Capsule group

    Group one received iodine capsule

    Dietary Supplement: Iodine capsule

  • Experimental
    Iodized salt group

    Group two received iodized salt

    Other: Iodized Salt

Interventions

  • Dietary supplementIodine capsule

    225 µg of iodine daily as a capsule of potassium iodide

  • OtherIodized Salt

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

06

What researchers measure

Primary outcomes

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

    Laboratory analysis

    Time frame: First week after delivery and at six months

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

    Laboratory analysis

    Time frame: First week after delivery and at six months

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

    Measurement

    Time frame: First week after delivery and at six months

Secondary outcomes

  1. Change from baseline thyroid hormones status at six months

    Laboratory analysis

    Time frame: First week after delivery and at six months

  2. Infants' visual information processing

    Looking behavior test

    Time frame: At six months after delivery

07

Study locations

1 site
  • Hawassa University
    Hawassa, Ethiopia
08

References and documents

Publications

  • Chan S, Kilby MD. Thyroid hormone and central nervous system development. J Endocrinol. 2000 Apr;165(1):1-8. doi: 10.1677/joe.0.1650001. No abstract available. PubMed 10750030 ↗
  • Zimmermann MB. The effects of iodine deficiency in pregnancy and infancy. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:108-17. doi: 10.1111/j.1365-3016.2012.01275.x. PubMed 22742605 ↗
  • Zimmermann MB. The Importance of Adequate Iodine during Pregnancy and Infancy. World Rev Nutr Diet. 2016;115:118-24. doi: 10.1159/000442078. Epub 2016 May 19. PubMed 27198746 ↗
  • Dold S, Zimmermann MB, Jukic T, Kusic Z, Jia Q, Sang Z, Quirino A, San Luis TOL, Fingerhut R, Kupka R, Timmer A, Garrett GS, Andersson M. Universal Salt Iodization Provides Sufficient Dietary Iodine to Achieve Adequate Iodine Nutrition during the First 1000 Days: A Cross-Sectional Multicenter Study. J Nutr. 2018 Apr 1;148(4):587-598. doi: 10.1093/jn/nxy015. PubMed 29659964 ↗
  • Robinson SM, Crozier SR, Miles EA, Gale CR, Calder PC, Cooper C, Inskip HM, Godfrey KM. Preconception Maternal Iodine Status Is Positively Associated with IQ but Not with Measures of Executive Function in Childhood. J Nutr. 2018 Jun 1;148(6):959-966. doi: 10.1093/jn/nxy054. PubMed 29767745 ↗
  • Vongchana M, Ounjaijean S, Tongsong T, Traisrisilp K. The effectiveness of iodine supplementation during pregnancies in geographical areas of high prevalence of iodine insufficiency. J Obstet Gynaecol. 2018 Aug;38(6):756-761. doi: 10.1080/01443615.2017.1410534. Epub 2018 Mar 12. PubMed 29526129 ↗
  • WHO Secretariat; Andersson M, de Benoist B, Delange F, Zupan J. Prevention and control of iodine deficiency in pregnant and lactating women and in children less than 2-years-old: conclusions and recommendations of the Technical Consultation. Public Health Nutr. 2007 Dec;10(12A):1606-11. doi: 10.1017/S1368980007361004. No abstract available. Erratum In: Public Health Nutr. 2008 Mar;11(3):327. PubMed 18053287 ↗
  • Zimmermann MB. Iodine deficiency in pregnancy and the effects of maternal iodine supplementation on the offspring: a review. Am J Clin Nutr. 2009 Feb;89(2):668S-72S. doi: 10.3945/ajcn.2008.26811C. Epub 2008 Dec 16. PubMed 19088150 ↗
  • Vejbjerg P, Knudsen N, Perrild H, Carle A, Laurberg P, Pedersen IB, Rasmussen LB, Ovesen L, Jorgensen T. Effect of a mandatory iodization program on thyroid gland volume based on individuals' age, gender, and preceding severity of dietary iodine deficiency: a prospective, population-based study. J Clin Endocrinol Metab. 2007 Apr;92(4):1397-401. doi: 10.1210/jc.2006-2580. Epub 2007 Jan 30. PubMed 17264188 ↗
  • Gebreegziabher T, Stoecker BJ. Comparison of two sources of iodine delivery on breast milk iodine and maternal and infant urinary iodine concentrations in southern Ethiopia: A randomized trial. Food Sci Nutr. 2017 Apr 7;5(4):921-928. doi: 10.1002/fsn3.477. eCollection 2017 Jul. PubMed 28748081 ↗
  • Kennedy T, Thomas DG, Woltamo T, Abebe Y, Hubbs-Tait L, Sykova V, Stoecker BJ, Hambidge KM. Growth and Visual Information Processing in Infants in Southern Ethiopia. J Appl Dev Psychol. 2008 Mar 1;29(2):129-140. doi: 10.1016/j.appdev.2007.12.003. PubMed 19684873 ↗
  • Reynolds GD. Infant visual attention and object recognition. Behav Brain Res. 2015 May 15;285:34-43. doi: 10.1016/j.bbr.2015.01.015. Epub 2015 Jan 14. PubMed 25596333 ↗
  • Santiago P, Velasco I, Muela JA, Sanchez B, Martinez J, Rodriguez A, Berrio M, Gutierrez-Repiso C, Carreira M, Moreno A, Garcia-Fuentes E, Soriguer F. Infant neurocognitive development is independent of the use of iodised salt or iodine supplements given during pregnancy. Br J Nutr. 2013 Sep 14;110(5):831-9. doi: 10.1017/S0007114512005880. Epub 2013 Feb 4. PubMed 23375074 ↗
  • Velasco I, Carreira M, Santiago P, Muela JA, Garcia-Fuentes E, Sanchez-Munoz B, Garriga MJ, Gonzalez-Fernandez MC, Rodriguez A, Caballero FF, Machado A, Gonzalez-Romero S, Anarte MT, Soriguer F. Effect of iodine prophylaxis during pregnancy on neurocognitive development of children during the first two years of life. J Clin Endocrinol Metab. 2009 Sep;94(9):3234-41. doi: 10.1210/jc.2008-2652. Epub 2009 Jun 30. PubMed 19567536 ↗
  • Delange F. Iodine requirements during pregnancy, lactation and the neonatal period and indicators of optimal iodine nutrition. Public Health Nutr. 2007 Dec;10(12A):1571-80; discussion 1581-3. doi: 10.1017/S1368980007360941. PubMed 18053281 ↗
  • Bouhouch RR, Bouhouch S, Cherkaoui M, Aboussad A, Stinca S, Haldimann M, Andersson M, Zimmermann MB. Direct iodine supplementation of infants versus supplementation of their breastfeeding mothers: a double-blind, randomised, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 Mar;2(3):197-209. doi: 10.1016/S2213-8587(13)70155-4. Epub 2013 Nov 22. PubMed 24622750 ↗
  • Antonangeli L, Maccherini D, Cavaliere R, Di Giulio C, Reinhardt B, Pinchera A, Aghini-Lombardi F. Comparison of two different doses of iodide in the prevention of gestational goiter in marginal iodine deficiency: a longitudinal study. Eur J Endocrinol. 2002 Jul;147(1):29-34. doi: 10.1530/eje.0.1470029. PubMed 12088916 ↗
  • Rohner F, Zimmermann M, Jooste P, Pandav C, Caldwell K, Raghavan R, Raiten DJ. Biomarkers of nutrition for development--iodine review. J Nutr. 2014 Aug;144(8):1322S-1342S. doi: 10.3945/jn.113.181974. Epub 2014 Jun 25. PubMed 24966410 ↗
  • Ghirri P, Lunardi S, Boldrini A. Iodine supplementation in the newborn. Nutrients. 2014 Jan 20;6(1):382-90. doi: 10.3390/nu6010382. PubMed 24448111 ↗
  • Taylor RM, Fealy SM, Bisquera A, Smith R, Collins CE, Evans TJ, Hure AJ. Effects of Nutritional Interventions during Pregnancy on Infant and Child Cognitive Outcomes: A Systematic Review and Meta-Analysis. Nutrients. 2017 Nov 20;9(11):1265. doi: 10.3390/nu9111265. PubMed 29156647 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2013 to primary completion in Jan 2013, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2019
First posted
Mar 26, 2019
StartActual
Jan 2, 2013
Primary completionActual
Jan 30, 2013
CompletionActual
Aug 10, 2013
Last update
Mar 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03889431
Lead sponsor
Oklahoma State University
Responsible party
Barbara Stoecker (Regents Professor, Oklahoma State University) — Principal investigator
First posted
Mar 26, 2019
Start date
Jan 2, 2013
Primary completion
Jan 30, 2013
Completion
Aug 10, 2013
Last update
Mar 26, 2019

Study contacts

Tafere Gebreegziabher, PhD
principal investigator · Central Washington University & Hawassa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Iodine

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