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Completed

NCT Number: NCT01985204

Iodine Supplementation in Obesity

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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Key information

Conditions

Iodine Deficiency Body Weight Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Subclinical Hypothyroidism

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universite Caddi Ayad, Faculte de Medecine et de Pharmacie, Marrakesh, Morocco

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodine tablet

Dietary Supplement

Iodine tablets containing 200 ug iodine as potassium iodate

Placebo Tablet

Dietary Supplement

Placebo tablet without iodine

Primary outcomes

  1. Change in TSH (thyroid-stimulating hormone)

    Time frame: change from baseline to 6 months

  2. change in fasting insulin

    Time frame: change from baseline to 6 months

  3. change in the LDL cholesterol/ HDL cholesterol ratio

    Time frame: change from baseline to 6 months

Secondary outcomes

  1. fasting glucose

    Time frame: baseline, 3 months and 6 months

  2. plasma leptin

    Time frame: baseline, 3 months and 6 months

  3. LDL cholesterol

    Time frame: baseline, 3 months and 6 months

  4. HDL cholesterol

    Time frame: baseline, 3 months and 6 months

  5. Urinary iodine

    Time frame: change from baseline to 6 months

Other outcomes

  1. T3

    Time frame: baseline, 3 months and 6 months

  2. T4

    Time frame: baseline, 3 months and 6 months

  3. total cholesterol

    Time frame: baseline, 3 months and 6 months

  4. TSH

    Time frame: 3 months

  5. leptin

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2013
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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