Clinical trial NCT01985204: Iodine Supplementation in Obesity
Official title: Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iodine Deficiency
Subclinical Hypothyroidism
Keywords: iodine
thyroid hormones
obesity
TSH
dyslipidemia
insulin resistance
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 162
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in TSH (thyroid-stimulating hormone)
timeFrame: change from baseline to 6 months
measure: change in fasting insulin
timeFrame: change from baseline to 6 months
measure: change in the LDL cholesterol/ HDL cholesterol ratio
timeFrame: change from baseline to 6 months
Secondary outcomes:
measure: fasting glucose
timeFrame: baseline, 3 months and 6 months
measure: plasma leptin
timeFrame: baseline, 3 months and 6 months
measure: LDL cholesterol
timeFrame: baseline, 3 months and 6 months
measure: HDL cholesterol
timeFrame: baseline, 3 months and 6 months
measure: Urinary iodine
timeFrame: change from baseline to 6 months
Other outcomes:
measure: T3
timeFrame: baseline, 3 months and 6 months
measure: T4
timeFrame: baseline, 3 months and 6 months
measure: total cholesterol
timeFrame: baseline, 3 months and 6 months
measure: TSH
timeFrame: 3 months
measure: leptin
timeFrame: 3 months
Locations:
city: Marrakech
country: Morocco
facility: Universite Caddi Ayad, Faculte de Medecine et de Pharmacie
city: Marrakech
country: Morocco
facility: University Cadi Ayyad, Faculte des Sciences
Study officials:
affiliation: ETH Zurich (Switzerland)
name: Isabelle Aeberli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.