Iodine Supplementation in Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

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.

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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.

Conditions

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Iodine Deficiency Subclinical Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo tablet

Intervention Type DIETARY_SUPPLEMENT

Placebo tablet without iodine

Intervention

Iodine tablet

Group Type EXPERIMENTAL

Iodine tablet

Intervention Type DIETARY_SUPPLEMENT

Iodine tablets containing 200 ug iodine as potassium iodate

Interventions

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Iodine tablet

Iodine tablets containing 200 ug iodine as potassium iodate

Intervention Type DIETARY_SUPPLEMENT

Placebo tablet

Placebo tablet without iodine

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes