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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889431
• Other study ID #: HE1156
• Status: Completed
• Phase: N/A
• Start date: January 2, 2013
• Est. completion date: August 10, 2013

Study information

• Verified date: March 2019
• Source: Oklahoma State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 10, 2013
• Est. primary completion date: January 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• Iodine Deficiency Goiter

Intervention

Dietary Supplement:
• Iodine capsule
225 µg of iodine daily as a capsule of potassium iodide

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

Locations

Country	Name	City	State
Ethiopia	Hawassa University	Hawassa

Sponsors (1)

Lead Sponsor	Collaborator
Oklahoma State University

Country where clinical trial is conducted

Ethiopia, 

References & Publications (20)

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. 2 — View Citation

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. Lanc — View Citation

Chan S, Kilby MD. Thyroid hormone and central nervous system development. J Endocrinol. 2000 Apr;165(1):1-8. Review. — View Citation

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. Review. — View Citation

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 10 — View Citation

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 — View Citation

Ghirri P, Lunardi S, Boldrini A. Iodine supplementation in the newborn. Nutrients. 2014 Jan 20;6(1):382-90. doi: 10.3390/nu6010382. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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: — View Citation

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. Review. — View Citation

Santiago P, Velasco I, Muela JA, Sánchez B, Martínez J, Rodriguez A, Berrio M, Gutierrez-Repiso C, Carreira M, Moreno A, García-Fuentes E, Soriguer F. Infant neurocognitive development is independent of the use of iodised salt or iodine supplements given — View Citation

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). pii: E1265. doi: 10 — View Citation

Vejbjerg P, Knudsen N, Perrild H, Carlé A, Laurberg P, Pedersen IB, Rasmussen LB, Ovesen L, Jørgensen T. Effect of a mandatory iodization program on thyroid gland volume based on individuals' age, gender, and preceding severity of dietary iodine deficienc — View Citation

Velasco I, Carreira M, Santiago P, Muela JA, García-Fuentes E, Sánchez-Muñoz B, Garriga MJ, González-Fernández MC, Rodríguez A, Caballero FF, Machado A, González-Romero S, Anarte MT, Soriguer F. Effect of iodine prophylaxis during pregnancy on neurocognit — View Citation

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: 10.1080/01443615.2017.14 — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline breast milk iodine concentration (µg/L) at six months	Laboratory analysis	First week after delivery and at six months
Primary	Change from baseline urinary iodine concentration (µg/L at six months	Laboratory analysis	First week after delivery and at six months
Primary	Change from baseline Infants' anthropometric measurement (Z-score) at six months	Measurement	First week after delivery and at six months
Secondary	Change from baseline thyroid hormones status at six months	Laboratory analysis	First week after delivery and at six months
Secondary	Infants' visual information processing	Looking behavior test	At six months after delivery