To study the joint and separate effects of vitamin E and zinc supplementation on serum levels of vitamin E, zinc, and antioxidants in beta thalassemia major patients
This double blind randomized clinical trial designed to determine the effects of zinc and vitamin E supplementation on oxidative stress in beta-thalassemic major patients. 120 beta thalassemic patients aged more than 18 years were randomly divided into four 30 subject groups to receive Zinc supplements 50 mg/day, vitamin E 400 mg/day, both of these supplements similar to mentioned dosages, or no supplements for 3 months. The effect of supplementations on serum zinc and vitamin E, superoxide dismutase, glutathione peroxidase, total antioxidant capacity, and body mass index were measured at the baseline and the end of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811033139N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Maryam Aboomardani
Name of organization / entity
Faculty of Health & Nutrition, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2292
Email address
aboomardani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Drug Applied Research Center & Nutrition Research Center of Tabriz University of Medical Sciences
Expected recruitment start date
2008-10-06, 1387/07/15
Expected recruitment end date
2009-02-08, 1387/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To study the joint and separate effects of vitamin E and zinc supplementation on serum levels of vitamin E, zinc, and antioxidants in beta thalassemia major patients
Public title
The effect of vitamin E and zinc supplementation on serum levels of vitamin E, zinc, and antioxidants in beta thalassemia major patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: history of continuous treatment with blood transfusion and desferal as a chellator agent.
Exclusion criteria: history of diabetes mellitus, smoking, hepatitis B and C and consumption of any supplements at least three month prior to the study.
Age
From 18 years old to 43 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Vice Chancellor of Tabriz University of Medical Sciences
Street address
University st., Golgasht st.
City
Tabriz
Postal code
5166614711
Approval date
empty
Ethics committee reference number
8732
Health conditions studied
1
Description of health condition studied
Beta Thalassemia major
ICD-10 code
D56.1
ICD-10 code description
Cooley's anaemia, Severe beta thalassaemia
Primary outcomes
1
Description
Serum level of vitamin E
Timepoint
3 months
Method of measurement
Enzymatic analysis
2
Description
Serum level of zinc
Timepoint
3 months
Method of measurement
enzymatic analysis
3
Description
glutathion peroxidase activity
Timepoint
3 months
Method of measurement
enzymatic analysis
4
Description
Body mass index
Timepoint
3 months
Method of measurement
Dividing weight (kg) by the second power of height(m)
Secondary outcomes
1
Description
Appetite
Timepoint
3 months
Method of measurement
Questionnaire
2
Description
Wellbeing
Timepoint
3 months
Method of measurement
questionnaire
Intervention groups
1
Description
cotrol group which did not recieve any supplements
Category
N/A
2
Description
Zinc sulfate, 220mg daily, orally for three months
Category
Treatment - Drugs
3
Description
Vitamin E, 400mg daily, orally for three months
Category
Treatment - Drugs
4
Description
Vitamin E, 400mg daily and Zinc sulfate, 220mg daily, orally for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospitals- Thalassemia Section- Gorgan
Full name of responsible person
Dr. Narges Beigom Mirbehbehani
Street address
in front of Army Hospital- Army boulvard, Gorgan,Iran
City
Gorgan
2
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Sadegh Ali Azimi
Street address
Amiralmomenin Hospital, End of park street, Kordkoy
City
Kordkoy
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Drug Applied Research Center, Nutrition Research Center, Tabriz University of Medical Science
Full name of responsible person
Dr. Hossein Babaei, Dr. Alireza Ostadrahimi
Street address
Nutrition Research Center, Faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st, Tabriz, Iran & University st. Pashmineh complex, Drug Applied Research Center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Drug Applied Research Center, Nutrition Research Center, Tabriz University of Medical Science
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
Nutrition Research Center of Tabriz University of Medical Scienes
Full name of responsible person
Dr. Maryam Rafraf
Position
An academic member of Tabriz University of Medical Sciences/ph.D in Nutrition Science
Other areas of specialty/work
Street address
Nutrition Research Center, Faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2292
Fax
+98 41 1336 3430
Email
rafrafm@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Research Center of Tabriz University of Medical Science
Full name of responsible person
Dr. Maryam Rafraf
Position
An academic member of Tabriz University of Medical sciences/ PhD in Nutrition Science
Other areas of specialty/work
Street address
Nutrition Research Center, Faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2292
Fax
+98 41 1336 3430
Email
rafrafm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Health & Nutrition Faculty of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Aboomardani
Position
Ph.D student of Nutrition
Other areas of specialty/work
Street address
Nutrition Research Center, Faculty of Health & Nutrition, Atar-Neishaboori st, Golgasht st, Tabriz, Iran
City
Tabriz
Postal code
5166614711
Phone
+98 41 1335 2292
Fax
+98 41 1336 3430
Email
aboomardani@goums.ac.iraboomardani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)