Iodine Supplementation in Obesity

Not Applicable

Completed

• Conditions: Subclinical Hypothyroidism; Iodine Deficiency
• Interventions: Dietary Supplement: Placebo tablet; Dietary Supplement: Iodine tablet

• Registration Number: NCT01985204
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-29
• Last Update Posted: 2014-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo tablet	Placebo tablet
Intervention	Iodine tablet	Iodine tablet

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
fasting glucose	baseline, 3 months and 6 months
LDL cholesterol	baseline, 3 months and 6 months
HDL cholesterol	baseline, 3 months and 6 months
Urinary iodine	change from baseline to 6 months
plasma leptin	baseline, 3 months and 6 months

Trial Locations

Locations (2)

Universite Caddi Ayad, Faculte de Medecine et de Pharmacie; 🇲🇦 Marrakech, Morocco

University Cadi Ayyad, Faculte des Sciences; 🇲🇦 Marrakech, Morocco