Iodine DeficiencyNCT01985204
Iodine Supplementation in Obesity
A study testing Iodine tablet in people with Iodine Deficiency and Subclinical Hypothyroidism, run by Swiss Federal Institute of Technology at 2 sites in Morocco.
Trial summary
The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iodine Deficiency, Subclinical Hypothyroidism
- What is being tested?
- Iodine tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 2 sitesMorocco
- Study dates
- Nov 2013to Jul 2014
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of reproductive age (20 to 50 years)
- Body mass index 27 to 40 kg/m2
- Having received oral and written information about the aims and procedures of the study
- Willing to comply with the study procedure
- Having provided oral and written informed consent
Who cannot join
- Chronic disease or gastrointestinal disorders
- Nodular goiter
- Regular use of medication (except oral contraceptives)
- Pregnancy or lactation
- Subject who cannot be expected to comply with study protocol
Trial locations and contacts
2 sites in 1 country.
Morocco2 sites
Universite Caddi Ayad, Faculte de Medecine et de Pharmacie
Marrakesh
University Cadi Ayyad, Faculte des Sciences
Marrakesh
About this study
Official title: Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.
Read the detailed description
The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.
- Conditions
- Iodine Deficiency, Subclinical Hypothyroidism
- Being tested
- Iodine tablet, Placebo tablet
- Keywords
- iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance
- Medical subject headings
- Obesity, Dyslipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine tabletDietary supplement
Iodine tablets containing 200 ug iodine as potassium iodate
Placebo tabletDietary supplement
Placebo tablet without iodine
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo tablet Receives: Dietary Supplement: Placebo tablet |
| Intervention | Experimental | Iodine tablet Receives: Dietary Supplement: Iodine tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TSH (thyroid-stimulating hormone)
Measured: change from baseline to 6 months
change in fasting insulin
Measured: change from baseline to 6 months
change in the LDL cholesterol/ HDL cholesterol ratio
Measured: change from baseline to 6 months
Secondary outcomes (5)
fasting glucose
Measured: baseline, 3 months and 6 months
plasma leptin
Measured: baseline, 3 months and 6 months
LDL cholesterol
Measured: baseline, 3 months and 6 months
HDL cholesterol
Measured: baseline, 3 months and 6 months
Urinary iodine
Measured: change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Aeberli, Swiss Federal Institute of Technology
- Investigators
- Isabelle Aeberli, PhD, Principal investigator, ETH Zurich (Switzerland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985204
- Sponsor's protocol ID
- EK 2013-N-24
- Status last verified
- Jul 2014
- First submitted
- 31 Oct 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Herter-Aeberli I, Cherkaoui M, El Ansari N, Rohner R, Stinca S, Chabaa L, von Eckardstein A, Aboussad A, Zimmermann MB. Iodine Supplementation Decreases Hypercholesterolemia in Iodine-Deficient, Overweight Women: A Randomized Controlled Trial. J Nutr. 2015 Sep;145(9):2067-75. doi: 10.3945/jn.115.213439. Epub 2015 Jul 22.
PubMed 26203098
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
- ClinicalTrials.gov ID
- NCT01985204
- Acronym / sponsor ID
- EK 2013-N-24
- Conditions
- Iodine Deficiency, Subclinical Hypothyroidism
- Keywords
- iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 Nov 2013 (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 study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.
Detailed description
The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo tabletPlacebo tablet |
| Intervention | Experimental | Dietary Supplement: Iodine tabletIodine tablet |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women of reproductive age (20 to 50 years)
- Body mass index 27 to 40 kg/m2
- Having received oral and written information about the aims and procedures of the study
- Willing to comply with the study procedure
- Having provided oral and written informed consent
Key exclusion criteria (5 listed)
- Chronic disease or gastrointestinal disorders
- Nodular goiter
- Regular use of medication (except oral contraceptives)
- Pregnancy or lactation
- Subject who cannot be expected to comply with study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine tabletIodine tablets containing 200 ug iodine as potassium iodate | Dietary supplement | Intervention |
| Placebo tabletPlacebo tablet without iodine | Dietary supplement | Placebo |
Primary outcome
Change in TSH (thyroid-stimulating hormone)
Time frame: change from baseline to 6 months
change in fasting insulin
Time frame: change from baseline to 6 months
change in the LDL cholesterol/ HDL cholesterol ratio
Time frame: change from baseline to 6 months
5 secondary outcomes
fasting glucose
Time frame: baseline, 3 months and 6 months
plasma leptin
Time frame: baseline, 3 months and 6 months
LDL cholesterol
Time frame: baseline, 3 months and 6 months
HDL cholesterol
Time frame: baseline, 3 months and 6 months
Urinary iodine
Time frame: change from baseline to 6 months
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 30 Jul 2014.
- Derived from this study: PubMed 26203098Herter-Aeberli I, Cherkaoui M, El Ansari N, Rohner R, Stinca S, Chabaa L, von Eckardstein A, Aboussad A, Zimmermann MB. Iodine Supplementation Decreases Hypercholesterolemia in Iodine-Deficient, Overweight Women: A Randomized Controlled Trial. J Nutr. 2015 Sep;145(9):2067-75. doi: 10.3945/jn.115.213439. Epub 2015 Jul 22.
Related trials for Iodine Deficiency
Not yet recruitingPhase 4
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Folate Deficiency, Neural Tube Defects
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The Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
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EUthyroid2: the Next Step Towards the Elimination of Iodine Deficiency and Preventable Iodine-related Disorders in Europe
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Active, not recruiting
The Bioavailability of Iodine in Plant-based Milk Alternatives
Iodine Deficiency
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.
Isabelle Aeberli, PhD principal investigator
ETH Zurich (Switzerland)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iodine tablet in people with Iodine Deficiency and Subclinical Hypothyroidism, run by Swiss Federal Institute of Technology at 2 sites in Morocco.
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 5 inclusion and 5 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 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Morocco. 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. Some participants in this study may receive a placebo. 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?
Change in TSH (thyroid-stimulating hormone) (time frame: change from baseline to 6 months). The study lists 3 primary outcomes in all. 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 NCT01985204, which also lists 1 linked publication.
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 30 Jul 2014.