Iodine Supplementation in Obesity
Cuvinte cheie
Abstract
Descriere
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.
Datele
| Ultima verificare: | 06/30/2014 |
| Primul depus: | 10/30/2013 |
| Inscriere estimată trimisă: | 11/07/2013 |
| Prima postare: | 11/14/2013 |
| Ultima actualizare trimisă: | 07/28/2014 |
| Ultima actualizare postată: | 07/29/2014 |
| Data actuală de începere a studiului: | 10/31/2013 |
| Data estimată de finalizare primară: | 05/31/2014 |
| Data estimată de finalizare a studiului: | 06/30/2014 |
Stare sau boală
Intervenție / tratament
Dietary Supplement: Intervention
Dietary Supplement: Placebo
Fază
Grupuri de brațe
| Braţ | Intervenție / tratament |
|---|---|
| Placebo Comparator: Placebo Placebo tablet | Dietary Supplement: Placebo Placebo tablet without iodine |
| Experimental: Intervention Iodine tablet | Dietary Supplement: Intervention Iodine tablets containing 200 ug iodine as potassium iodate |
Criterii de eligibilitate
| Vârste eligibile pentru studiu | 20 Years La 20 Years |
| Sexe eligibile pentru studiu | Female |
| Acceptă voluntari sănătoși | da |
| Criterii | 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 |
Rezultat
Măsuri de rezultate primare
1. Change in TSH (thyroid-stimulating hormone) [change from baseline to 6 months]
2. change in fasting insulin [change from baseline to 6 months]
3. change in the LDL cholesterol/ HDL cholesterol ratio [change from baseline to 6 months]
Măsuri de rezultate secundare
1. fasting glucose [baseline, 3 months and 6 months]
2. plasma leptin [baseline, 3 months and 6 months]
3. LDL cholesterol [baseline, 3 months and 6 months]
4. HDL cholesterol [baseline, 3 months and 6 months]
5. Urinary iodine [change from baseline to 6 months]
Alte măsuri de rezultat
1. T3 [baseline, 3 months and 6 months]
2. T4 [baseline, 3 months and 6 months]
3. total cholesterol [baseline, 3 months and 6 months]
4. TSH [3 months]
5. leptin [3 months]
