Iodine Supplementation in Obesity

Study Overview
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Brief Summary
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The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.

Detailed Description
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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.

Official Title
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Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency

Conditions
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Iodine Deficiency, Subclinical Hypothyroidism

Intervention / Treatment
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* Dietary Supplement: Iodine tablet
* Dietary Supplement: Placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo tablet | Dietary Supplement: Placebo tablet<br>* Placebo tablet without iodine<br>|
| Experimental: Intervention<br>Iodine tablet | Dietary Supplement: Iodine tablet<br>* Iodine tablets containing 200 ug iodine as potassium iodate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance