Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy

NCT ID: NCT02196337

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to determine whether universal salt iodization (USI) meets the iodine requirements of pregnant women, lactating women and infants.

Detailed Description

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Because pregnant women, lactating women and infants are the groups most vulnerable to iodine deficiency and its irreversible consequences, programs should focus on these groups. But like other mass fortification strategies, it is uncertain whether USI can meet the increased dietary requirements of pregnant women, lactating women and infants. Objective of this study to test whether USI can meet the dietary requirements of iodine in women of reproductive age, pregnant women, lactating women and infants up to 2 years of age without causing excess iodine intake in school children and non-pregnant non-lactating women. The study hypothesis is that USI, when fortified at adequate levels and applied to all salt consumed, including both household salt and salt used for processed foods, provides adequate dietary iodine for all population groups, except for weaning infants; while not posing any risk of excessive iodine intakes in other age groups.

Conditions

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Iodine Deficiency

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Women of reproductive age

Age: 18-44 years

No interventions assigned to this group

Pregnant women

Age: 18-44 years

No interventions assigned to this group

Lactating women

Age: 18-44 years

No interventions assigned to this group

Young infants

Age: younger than 6 months

No interventions assigned to this group

Toddlers

Age: between 6 and 24 months

No interventions assigned to this group

School-aged children

Age: 6-12 years

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* living at study area for at least 6 months
* generally healthy
* no chronic medication
* no history of thyroid disease in the family
* no use of iodine containing dietary supplements during the last 6 months
* no use of iodine containing disinfectants for the last 6 months
* no use of X-ray / CT contrast agent or iodine containing medication within the last year
* in addition for women of reproductive age, pregnant women and breastfeeding women: age between 18 and 44 years old
* in addition for pregnant women: healthy pregnancy, singleton pregnancy (no twins or multiple pregnancy)
* in addition for breastfeeding women and breastfed infants: healthy pregnancy, singleton pregnancy (no twins or multiple pregnancy), baby born at full-term (in pregnancy week 38 to 42), the baby had normal birth weight (≥ 2500 g), baby not older than 6 months, baby currently completely breastfed (except for water, tea and juices)
* in addition for toddlers: between 6 and 24 months old
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role collaborator

St. Luke's Medical Center

OTHER

Sponsor Role collaborator

Global Alliance for Improved Nutrition

OTHER

Sponsor Role collaborator

UNICEF

OTHER

Sponsor Role collaborator

Shanxi Institute for Prevention and Treatment of Endemic Disease

UNKNOWN

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Maria Andersson

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Andersson, PhD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

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Shanxi Institute for Prevention and Treatment of Endemic Disease

Linfen, Shanxi, China

Site Status

University of Zagreb

Zagreb, , Croatia

Site Status

University of Santo Tomas Hospital

Manila, , Philippines

Site Status

ETH Zurich

Zurich, , Switzerland

Site Status

Countries

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China Croatia Philippines Switzerland

References

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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.

Reference Type DERIVED
PMID: 29659964 (View on PubMed)

Dold S, Zimmermann MB, Aboussad A, Cherkaoui M, Jia Q, Jukic T, Kusic Z, Quirino A, Sang Z, San Luis TO, Vandea E, Andersson M. Breast Milk Iodine Concentration Is a More Accurate Biomarker of Iodine Status Than Urinary Iodine Concentration in Exclusively Breastfeeding Women. J Nutr. 2017 Apr;147(4):528-537. doi: 10.3945/jn.116.242560. Epub 2017 Feb 22.

Reference Type DERIVED
PMID: 28228508 (View on PubMed)

Other Identifiers

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EK 2013-N-82

Identifier Type: -

Identifier Source: org_study_id

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