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

NCT03889431 | Completed

• 1 other identifier: HE1156
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Iodine Deficiency Goiter; Infant Development

Outcome Measures

Primary Outcomes (3)

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

  Laboratory analysis

  First week after delivery and at six months

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

  Laboratory analysis

  First week after delivery and at six months

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

  Measurement

  First week after delivery and at six months

Secondary Outcomes (2)

• Change from baseline thyroid hormones status at six months

  First week after delivery and at six months

• Infants' visual information processing

  At six months after delivery

Study Arms (2)

Capsule group

EXPERIMENTAL

Group one received iodine capsule

Dietary Supplement: Iodine capsule

Iodized salt group

EXPERIMENTAL

Group two received iodized salt

Other: Iodized Salt

Interventions

Iodine capsule DIETARY_SUPPLEMENT

225 µg of iodine daily as a capsule of potassium iodide

Capsule group

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

Iodized salt group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oklahoma State University: lead

Study Sites (1)

Hawassa University

Awasa, Ethiopia

Location

Related Publications (20)

• 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.

  PMID: 10750030 RESULT

• 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.

  PMID: 22742605 RESULT

• 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.

  PMID: 27198746 RESULT

• 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.

  PMID: 29659964 RESULT

• 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.

  PMID: 29767745 RESULT

• 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.

  PMID: 29526129 RESULT

• 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.

  PMID: 18053287 RESULT

• 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.

  PMID: 19088150 RESULT

• 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.

  PMID: 17264188 RESULT

• 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.

  PMID: 28748081 RESULT

• 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.

  PMID: 19684873 RESULT

• 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.

  PMID: 25596333 RESULT

• 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.

  PMID: 23375074 RESULT

• 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.

  PMID: 19567536 RESULT

• 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.

  PMID: 18053281 RESULT

• 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.

  PMID: 24622750 RESULT

• 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.

  PMID: 12088916 RESULT

• 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.

  PMID: 24966410 RESULT

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

  PMID: 24448111 RESULT

• 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.

  PMID: 29156647 RESULT

MeSH Terms

Interventions

Iodine; iodized salt

Intervention Hierarchy (Ancestors)

Halogens; Elements; Inorganic Chemicals

Study Officials

• Tafere Gebreegziabher, PhD

  Central Washington University & Hawassa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regents Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 26, 2019
• Study Start: January 2, 2013
• Primary Completion: January 30, 2013
• Study Completion: August 10, 2013
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)