Iodine DeficiencySIMPLIFYNCT02196337
Salt Iodization: Meeting the Needs of Pregnancy, Lactation and Infancy
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 4 sites in 4 countries.
Trial summary
The purpose of this study is to determine whether universal salt iodization (USI) meets the iodine requirements of pregnant women, lactating women and infants. Read more about this study
- Who is it for?
- Ages 2 weeks to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency
- How many people
- 8,000 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jul 2014to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 44 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: In each of the four study countries, six population groups will be studied: * women of reproductive age * pregnant women * lactating women * young infants * toddlers * school-aged children
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
China1 site
Shanxi Institute for Prevention and Treatment of Endemic Disease
Linfen, Shanxi, 041000
About this study
Official title: Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?
The purpose of this study is to determine whether universal salt iodization (USI) meets the iodine requirements of pregnant women, lactating women and infants.
Read the detailed description
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
- Iodine Deficiency
- Keywords
- Iodine deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women of reproductive age | Age: 18-44 years | |
| Pregnant women | Age: 18-44 years | |
| Lactating women | Age: 18-44 years | |
| Young infants | Age: younger than 6 months | |
| Toddlers | Age: between 6 and 24 months | |
| School-aged children | Age: 6-12 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary iodine concentration (µg/L)
Participants will be assessed only once. However, for 30% of the study participants urinary iodine concentration will be assessed in spot samples collected on two different days, spread over an expected average of 5 days.
Measured: 1 day
Secondary outcomes (2)
Thyroglobulin (µg/L)
Thyroglobulin will be measured in all population groups
Measured: 1 day
Breast milk iodine concentration (µg/L)
Breast milk iodine concentration will be measured in lactating women.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Iodine DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb, St. Luke's Medical Center, Global Alliance for Improved Nutrition, UNICEF, Shanxi Institute for Prevention and Treatment of Endemic Disease
- Responsible party
- Principal investigator, Maria Andersson, Swiss Federal Institute of Technology
- Investigators
- Maria Andersson, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196337
- Sponsor's protocol ID
- EK 2013-N-82
- Acronym
- SIMPLIFY
- Status last verified
- Apr 2016
- First submitted
- 2 Jun 2014
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 29659964Dold 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.
PubMed 28228508
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salt Iodization and the 1st 1000 Days: Does a USI Program Cover the Iodine Requirement of Pregnant and Lactating Women and Infants?
- ClinicalTrials.gov ID
- NCT02196337
- Acronym / sponsor ID
- SIMPLIFY / EK 2013-N-82
- Conditions
- Iodine Deficiency
- Keywords
- Iodine deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Zagreb, St. Luke's Medical Center, Global Alliance for Improved Nutrition, UNICEF, Shanxi Institute for Prevention and Treatment of Endemic Disease
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Women of reproductive age | – | –Age: 18-44 years |
| Pregnant women | – | –Age: 18-44 years |
| Lactating women | – | –Age: 18-44 years |
| Young infants | – | –Age: younger than 6 months |
| Toddlers | – | –Age: between 6 and 24 months |
| School-aged children | – | –Age: 6-12 years |
Who may qualify
- Ages
- 2 weeks to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In each of the four study countries, six population groups will be studied: * women of reproductive age * pregnant women * lactating women * young infants * toddlers * school-aged children
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urinary iodine concentration (µg/L)
Time frame: 1 day
Participants will be assessed only once. However, for 30% of the study participants urinary iodine concentration will be assessed in spot samples collected on two different days, spread over an expected average of 5 days.
2 secondary outcomes
Thyroglobulin (µg/L)
Time frame: 1 day
Breast milk iodine concentration (µg/L)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Derived from this study: PubMed 29659964Dold 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.
- Derived from this study: PubMed 28228508Dold 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Andersson, PhD principal investigator
ETH Zurich
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iodine Deficiency, run by Swiss Federal Institute of Technology at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China, Croatia, Philippines, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary iodine concentration (µg/L) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.