Iodine Supplementation in Obesity

N/ACompletedNCT01985204

Swiss Federal Institute of Technology162 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

162

Conditions

Iodine Deficiency Subclinical Hypothyroidism

Interventions

Iodine tabletDIETARY_SUPPLEMENT

Iodine tablets containing 200 ug iodine as potassium iodate

Placebo tabletDIETARY_SUPPLEMENT

Placebo tablet without iodine

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Universite Caddi Ayad, Faculte de Medecine et de Pharmacie

Marrakesh, Morocco

University Cadi Ayyad, Faculte des Sciences

Marrakesh, Morocco

Outcomes

Primary Outcomes

Change in TSH (thyroid-stimulating hormone)

Time frame: change from baseline to 6 months

change in fasting insulin

Time frame: change from baseline to 6 months

change in the LDL cholesterol/ HDL cholesterol ratio

Time frame: change from baseline to 6 months

Secondary Outcomes

fasting glucose

Time frame: baseline, 3 months and 6 months

plasma leptin

Time frame: baseline, 3 months and 6 months

LDL cholesterol

Time frame: baseline, 3 months and 6 months

HDL cholesterol

Time frame: baseline, 3 months and 6 months

Urinary iodine

Time frame: change from baseline to 6 months

Data from ClinicalTrials.gov

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