Effects of Single and Combined Zinc & Selenium Supplementation on Anthropometric measurments, metabolic rate & Thyroid Hormone Concentrations in Hypothyroid Overweight or Obese Patients.
We have designed a double-blind, placebo-controlled, randomized trial to investigate whether single and combined Zinc & Selenium supplementation improve anthropometric measurments, metabolic rate & thyroid hormone concentrations in Hypothyroid Overweight or Obese Patients. Sixty eight, aged 25-65 years old, hypothyroidism patients, who is eligible for this study, will be recruited from Firouzgar Hospital. Participants randomly allocated in four groups, receiving supplementation of zinc, selenium, zinc + selenium or placebo for 12 weeks. Thyroid hormone levels, resting metabolic rate & body composition will be measured at the baseline and the end of the study
General information
Acronym
Zinc & Selenium & Hypothyroidism
IRCT registration information
IRCT registration number:IRCT201112182365N4
Registration date:2012-05-02, 1391/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-02, 1391/02/13
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical sciences, vice-chancellor of research, Dr. Ali Akbar Fotohi.
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Single and Combined Zinc & Selenium Supplementation on Anthropometric measurments, metabolic rate & Thyroid Hormone Concentrations in Hypothyroid Overweight or Obese Patients.
Public title
Effects of Single and Combined Zinc & Selenium Supplementation on Anthropometric measurments, metabolic rate & Thyroid Hormone Concentrations in Hypothyroid Overweight or Obese Patients.
Purpose
Supportive
Inclusion/Exclusion criteria
In this study Hypothyroid patients are recruited from Firouzgar Hospital of Tehran university of medical sciences
Inclusion criteria: patients consensus; age 25 to 65 years old; BMI= 25-40 kg/m²;
Exclusion Criteria: Unwillingness to continue the study; compliance below the 80 percent; having history of Diabetes; Hypertension; cardiovascular diseases; gastrointestinal diseases; anemia; pregnant or lactating women; alcohol consumer or Cigarette smoker, Taking any supplements including vitamins & minerals in last 3 months.
Age
From 25 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences, School of Public health
Street address
Arjantin Square, Alvand Avenue, School of Public Health
City
Tehran
Postal code
Approval date
2012-04-24, 1391/02/05
Ethics committee reference number
49454
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03.9
ICD-10 code description
Hypothyroidism, unspecified
Primary outcomes
1
Description
Thyroid Hormones
Timepoint
12 weeks
Method of measurement
Radioimmunoassay
Secondary outcomes
1
Description
Body Composition
Timepoint
12 weeks
Method of measurement
Body Composition Analyser
2
Description
Basal Metabolic Rate
Timepoint
12 weeks
Method of measurement
Body Composition Analyser
Intervention groups
1
Description
Dietary Zinc supplement, 30 mg/d and dietary Selenium supplement 200 µg/d for 12 weeks
Category
Treatment - Other
2
Description
Placebo, the same as zinc tablet as the active supplement with the same size, daily for 12 weeks and Placebo, the same as selenium tablet as the active supplement with the same size, daily for 12 weeks.
Category
Placebo
3
Description
Dietary Zinc supplement, 30 mg, daily for 12 weeks , and Placebo, the same as selenium tablet as the active supplement with the same size, daily for 12 weeks.
Category
Treatment - Drugs
4
Description
Dietary selenium supplement, 200 µg, daily for 12 weeks , and Placebo, the same as zinc tablet as the active supplement with the same size, daily for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Endocrinology Clinic
Full name of responsible person
Mohammad Reza Vafa
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Street address
Arjantin Square, Alvand Avenue, School of Public Health
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
Arjantin Square, Alvand Avenue, School of Public Health
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
rezavafa@yahoo.commrvafa@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health(Alvand Campus), Tehran,Arjantin square, Alvand Ave.
City
Tehran
Postal code
Phone
+98 21 8877 9119
Fax
Email
mrvafa@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Vafa
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health(Alvand Campus), Tehran,Arjantin square, Alvand Ave.
City
Tehran
Postal code
Phone
+218 8779119
Fax
Email
mrvafa@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)