Iodine Supplementation in Obesity

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01985204
• Date of registration: 31/10/2013
• Prospective Registration: Yes
• Primary sponsor: Swiss Federal Institute of Technology
• Public title: Iodine Supplementation in Obesity
• Scientific title: Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
• Date of first enrolment: November 2013
• Target sample size: 162
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01985204
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Morocco

Contacts

• Name: Isabelle Aeberli, PhD
• Affiliation: ETH Zurich, Switzerland

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Subclinical Hypothyroidism

Iodine Deficiency

Intervention(s)

Dietary Supplement: Iodine tablet

Dietary Supplement: Placebo tablet

Primary Outcome(s)

Change in TSH (thyroid-stimulating hormone) [Time Frame: change from baseline to 6 months]

change in fasting insulin [Time Frame: change from baseline to 6 months]

change in the LDL cholesterol/ HDL cholesterol ratio [Time Frame: change from baseline to 6 months]

Secondary Outcome(s)

fasting glucose [Time Frame: baseline, 3 months and 6 months]

LDL cholesterol [Time Frame: baseline, 3 months and 6 months]

HDL cholesterol [Time Frame: baseline, 3 months and 6 months]

plasma leptin [Time Frame: baseline, 3 months and 6 months]

Urinary iodine [Time Frame: change from baseline to 6 months]

Secondary ID(s)

EK 2013-N-24

Source(s) of Monetary Support

Please refer to primary and secondary sponsors