Iodine Supplementation in Obesity

Iodine Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01985204
• Other study ID #: EK 2013-N-24
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: July 29, 2014
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hypothyroidism
• Iodine Deficiency
• Subclinical Hypothyroidism

Intervention

Dietary Supplement:
• Iodine tablet
Iodine tablets containing 200 ug iodine as potassium iodate
• Placebo tablet
Placebo tablet without iodine

Locations

Country	Name	City	State
Morocco	Universite Caddi Ayad, Faculte de Medecine et de Pharmacie	Marrakech
Morocco	University Cadi Ayyad, Faculte des Sciences	Marrakech

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	T3		baseline, 3 months and 6 months	No
Other	T4		baseline, 3 months and 6 months	No
Other	total cholesterol		baseline, 3 months and 6 months	No
Other	TSH		3 months	No
Other	leptin		3 months	No
Primary	Change in TSH (thyroid-stimulating hormone)		change from baseline to 6 months	No
Primary	change in fasting insulin		change from baseline to 6 months	No
Primary	change in the LDL cholesterol/ HDL cholesterol ratio		change from baseline to 6 months	No
Secondary	fasting glucose		baseline, 3 months and 6 months	No
Secondary	plasma leptin		baseline, 3 months and 6 months	No
Secondary	LDL cholesterol		baseline, 3 months and 6 months	No
Secondary	HDL cholesterol		baseline, 3 months and 6 months	No
Secondary	Urinary iodine		change from baseline to 6 months	No