Iodine Deficiency, Subclinical Hypothyroidism
Conditions
Keywords
iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance
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.
Interventions
DIETARY_SUPPLEMENTIodine tablet
Iodine tablets containing 200 ug iodine as potassium iodate
DIETARY_SUPPLEMENTPlacebo tablet
Placebo tablet without iodine
Sponsors
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in TSH (thyroid-stimulating hormone) | change from baseline to 6 months |
| change in the LDL cholesterol/ HDL cholesterol ratio | change from baseline to 6 months |
| change in fasting insulin | change from baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| plasma leptin | baseline, 3 months and 6 months |
| fasting glucose | 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
| Measure | Time frame |
|---|---|
| total cholesterol | baseline, 3 months and 6 months |
| leptin | 3 months |
| T4 | baseline, 3 months and 6 months |
| T3 | baseline, 3 months and 6 months |
| TSH | 3 months |
Countries
Morocco
Outcome results
None listed