Iodine Supplementation in Obesity

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iodine Deficiency; Subclinical Hypothyroidism

Treatments: Dietary Supplement: Placebo tablet; Dietary Supplement: Iodine tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT01985204

EK 2013-N-24

Details and patient eligibility

About

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

Full 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.

Enrollment: 162 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Dietary Supplement: Placebo tablet

Intervention

Experimental group

Description:

Iodine tablet

Treatment:

Dietary Supplement: Iodine tablet