The effects of Zn, vitamin A and magnesium supplementation on anthropometric parameters, metabolic, thyroid hormones, oxidative stress and hs-CRP in patients with hypothyroidism
We have designed a double-blind, placebo-controlled, randomized trial to investigate whether combined zinc، vitamin A and magnesium supplementation improve anthropometric measurments, metabolic rate ،thyroid hormone، oxidative stress and hs-CRP concentrations in Hypothyroid Patients. eighty eight , aged 20-65 years old, hypothyroidism patients, who is eligible for this study, will be recruited from Endocrine and Metabolism Research Institute of Iran University of Medical Sciences. Participants randomly allocated in two groups, receiving supplementation of zinc, vitamin A and magnesium or placebo for 10 weeks. Thyroid hormone levels, resting metabolic rate، body composition، oxidative stress and hs-CRP will be measured at the baseline and the end of the study
General information
Acronym
zinc AND vitamin A and magnesium and hypothyroidism
IRCT registration information
IRCT registration number:IRCT201709042365N17
Registration date:2017-09-23, 1396/07/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-23, 1396/07/01
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
vice chanceller of research ، Iran University of Medical Sciences
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-07-01, 1397/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Zn, vitamin A and magnesium supplementation on anthropometric parameters, metabolic, thyroid hormones, oxidative stress and hs-CRP in patients with hypothyroidism
Public title
The effects of Zn, vitamin A and magnesium supplementation on patients with hypothyroidism
Purpose
Supportive
Inclusion/Exclusion criteria
Hypothyroid patients referring to Endocrine and Metabolism Research Institute of Iran University of Medical Sciences who have the following criteria and express their willingness to cooperate.
Inclusion criteria: patients consensus; age 20 to 65 years old; BMI < 30 kg/m2; Drug therapy with levothyroxine; 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; digestive complications for supplements; Changing the dosage of the drug in the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
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
Iran University of Medical Sciences
Street address
Hemmat Highway, IUMS
City
Tehran
Postal code
Approval date
2017-09-02, 1396/06/11
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9411468007
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
Before intervention and 10 weeks after intervention
Method of measurement
ELIZA
Secondary outcomes
1
Description
MDA
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
measurement kit
2
Description
hs-CRP
Timepoint
Before intervention and10 weeks after intervention
Method of measurement
ELIZA
3
Description
Body Composition
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
Body Composition Analyser
4
Description
Basal Metabolic Rate
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
Body Composition Analyser
5
Description
TAC
Timepoint
Before intervention and 10 weeks after intervention
Method of measurement
measurement kit
Intervention groups
1
Description
Dietary Zinc supplement, 30 mg/d، Dietary vitamin A supplement, 25000 IU twice a week and Dietary magnesium supplement, 250 mg/d for 10 weeks
Category
Treatment - Other
2
Description
Placebo, the same as zinc tablet as the active supplement with the same size, daily for 10 weeks، Placebo, the same as magnesium tablet as the active supplement with the same size, daily for 10 weeks and Placebo, the same as vitamin A capsule as the active supplement with the same size, twice a week for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Vafa
Street address
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Moosavi
Street address
University Research Assistant, Headquarter Bulding, Iran University Of Medical Sciences, Beside Milad hospital, Shahid Hemat high way, Tehran, Iran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way
City
tehran
Postal code
Phone
+98 21 8670 4743
Fax
+98 21 8862 2707
Email
vafa.m@iums.ac.ir; rezavafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way
City
tehran
Postal code
Phone
+98 21 8670 4743
Fax
+98 21 8862 2707
Email
vafa.m@iums.ac.ir; rezavafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Express way
City
tehran
Postal code
Phone
+98 21 8670 4743
Fax
+98 21 8862 2707
Email
vafa.m@iums.ac.ir; rezavafa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)