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Iodine Supplementation in Obesity

Primary Purpose

Iodine Deficiency, Subclinical Hypothyroidism

Status
Completed
Phase
Not Applicable
Locations
Morocco
Study Type
Interventional
Intervention
Iodine tablet
Placebo tablet
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iodine Deficiency focused on measuring iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Intervention

Arm Description

Placebo tablet

Iodine tablet

Outcomes

Primary Outcome Measures

Change in TSH (thyroid-stimulating hormone)
change in fasting insulin
change in the LDL cholesterol/ HDL cholesterol ratio

Secondary Outcome Measures

fasting glucose
plasma leptin
LDL cholesterol
HDL cholesterol
Urinary iodine

Full Information

First Posted
October 31, 2013
Last Updated
July 29, 2014
Sponsor
Swiss Federal Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01985204
Brief Title
Iodine Supplementation in Obesity
Official Title
Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iodine Deficiency, Subclinical Hypothyroidism
Keywords
iodine, thyroid hormones, obesity, TSH, dyslipidemia, insulin resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Iodine tablet
Intervention Type
Dietary Supplement
Intervention Name(s)
Iodine tablet
Intervention Description
Iodine tablets containing 200 ug iodine as potassium iodate
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo tablet
Intervention Description
Placebo tablet without iodine
Primary Outcome Measure Information:
Title
Change in TSH (thyroid-stimulating hormone)
Time Frame
change from baseline to 6 months
Title
change in fasting insulin
Time Frame
change from baseline to 6 months
Title
change in the LDL cholesterol/ HDL cholesterol ratio
Time Frame
change from baseline to 6 months
Secondary Outcome Measure Information:
Title
fasting glucose
Time Frame
baseline, 3 months and 6 months
Title
plasma leptin
Time Frame
baseline, 3 months and 6 months
Title
LDL cholesterol
Time Frame
baseline, 3 months and 6 months
Title
HDL cholesterol
Time Frame
baseline, 3 months and 6 months
Title
Urinary iodine
Time Frame
change from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
T3
Time Frame
baseline, 3 months and 6 months
Title
T4
Time Frame
baseline, 3 months and 6 months
Title
total cholesterol
Time Frame
baseline, 3 months and 6 months
Title
TSH
Time Frame
3 months
Title
leptin
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Aeberli, PhD
Organizational Affiliation
ETH Zurich (Switzerland)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite Caddi Ayad, Faculte de Medecine et de Pharmacie
City
Marrakech
Country
Morocco
Facility Name
University Cadi Ayyad, Faculte des Sciences
City
Marrakech
Country
Morocco

12. IPD Sharing Statement

Citations:
PubMed Identifier
26203098
Citation
Herter-Aeberli I, Cherkaoui M, El Ansari N, Rohner R, Stinca S, Chabaa L, von Eckardstein A, Aboussad A, Zimmermann MB. Iodine Supplementation Decreases Hypercholesterolemia in Iodine-Deficient, Overweight Women: A Randomized Controlled Trial. J Nutr. 2015 Sep;145(9):2067-75. doi: 10.3945/jn.115.213439. Epub 2015 Jul 22.
Results Reference
derived

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Iodine Supplementation in Obesity

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