Iodine Supplementation in Obesity
Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
1 other identifier
interventional
162
1 country
2
Brief Summary
The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2013
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 30, 2014
July 1, 2014
7 months
October 31, 2013
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in TSH (thyroid-stimulating hormone)
change from baseline to 6 months
change in fasting insulin
change from baseline to 6 months
change in the LDL cholesterol/ HDL cholesterol ratio
change from baseline to 6 months
Secondary Outcomes (5)
fasting glucose
baseline, 3 months and 6 months
plasma leptin
baseline, 3 months and 6 months
LDL cholesterol
baseline, 3 months and 6 months
HDL cholesterol
baseline, 3 months and 6 months
Urinary iodine
change from baseline to 6 months
Other Outcomes (5)
T3
baseline, 3 months and 6 months
T4
baseline, 3 months and 6 months
total cholesterol
baseline, 3 months and 6 months
- +2 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo tablet
Intervention
EXPERIMENTALIodine tablet
Interventions
Iodine tablets containing 200 ug iodine as potassium iodate
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Universite Caddi Ayad, Faculte de Medecine et de Pharmacie
Marrakesh, Morocco
University Cadi Ayyad, Faculte des Sciences
Marrakesh, Morocco
Related Publications (1)
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.
PMID: 26203098DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle Aeberli, PhD
ETH Zurich (Switzerland)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 15, 2013
Study Start
November 1, 2013
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
July 30, 2014
Record last verified: 2014-07