Iodine Supplementation in Obesity

July 29, 2014 updated by: Isabelle Aeberli, Swiss Federal Institute of Technology

Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Marrakech, Morocco
        • Universite Caddi Ayad, Faculte de Medecine et de Pharmacie
      • Marrakech, Morocco
        • University Cadi Ayyad, Faculte des Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo tablet
Dietary supplement: Placebo tablet
Placebo tablet without iodine
Experimental: Intervention
Iodine tablet
Dietary supplement: Iodine tablet
Iodine tablets containing 200 ug iodine as potassium iodate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in TSH (thyroid-stimulating hormone)
Time Frame: change from baseline to 6 months
change from baseline to 6 months
change in fasting insulin
Time Frame: change from baseline to 6 months
change from baseline to 6 months
change in the LDL cholesterol/ HDL cholesterol ratio
Time Frame: change from baseline to 6 months
change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting glucose
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
plasma leptin
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
LDL cholesterol
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
HDL cholesterol
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
Urinary iodine
Time Frame: change from baseline to 6 months
change from baseline to 6 months

Other Outcome Measures

Outcome Measure
Time Frame
T3
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
T4
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
total cholesterol
Time Frame: baseline, 3 months and 6 months
baseline, 3 months and 6 months
TSH
Time Frame: 3 months
3 months
leptin
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 8, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2014

Last Update Submitted That Met QC Criteria

July 29, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 2013-N-24

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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