The purpose of this double blind clinical trial is to determine the effect of vitamin E & C, alone and in combination, on the improvement of asthma. 80 asthmatic patients, referred to Mofateh Special Clinics and Yasuj Imam Sajjad Hospital, will be randomly assigned into one of following groups to receive 400 mg Vitamin E per day, 800 mg vitamin C, 400 mg Vitamin E as well as 800 mg vitamin C, or placebo for 12 weeks. Holms-Rahe questionnaire was used to investigate daily stress. Dietary intake is measured using 24-hour dietary recalls questionnaire and respiratory factors are measured by peak flow meter and Spiro meter. Severity of asthma and the serum levels of vitamin C and E are measured before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904224359N1
Registration date:2010-09-13, 1389/06/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-09-13, 1389/06/22
Registrant information
Name
Leila Nikrooz
Name of organization / entity
Yasouj Univercity Medical Siencese
Country
Iran (Islamic Republic of)
Phone
+98 74 1223 4115
Email address
l-nikrooz@yums.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2010-11-22, 1389/09/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vitamin E and C supplements on improving asthma
Public title
Effect of Vitamin E and C supplements on improving asthma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: History of at least one year asthma, age 18-50 years
Exclusion Criteria: suffering from other diseases other than asthma, smoking, consumption of contraceptive pills
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Imam Sajjad Hospital, Yasouj, Kohgiluyeh and Boyer Ahmad Province
City
Yasuj
Postal code
Approval date
2010-03-16, 1388/12/25
Ethics committee reference number
7873/5/23/پ
Health conditions studied
1
Description of health condition studied
Asthma
ICD-10 code
J45
ICD-10 code description
Asthma
Primary outcomes
1
Description
Asthma severity (severe - moderate - mild)
Timepoint
Before intervention and 6 and 12 weeks after intervention
Method of measurement
Classification of Asthma Severity: Method of Australian national Asthma Campaign 1998
Secondary outcomes
1
Description
Serum levels of vitamins A and C
Timepoint
Before and after intervention
Method of measurement
Serum levels of vitamins A and C
2
Description
stress
Timepoint
Before and after intervention
Method of measurement
The holms- Rahe stress scale
3
Description
dietary intake
Timepoint
before and after intervention
Method of measurement
a 24 hours dietary recall
Intervention groups
1
Description
400 mg of vitamin E, daily, for 12 weeks
Category
Treatment - Drugs
2
Description
Placebo (starch powder) for 12 weeks
Category
Placebo
3
Description
800 mg of vitamin C, daily for 12 weeks
Category
Treatment - Drugs
4
Description
400 mg of Vitamin E plus 800 mg ascorbic acid, daily for 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofatteh Clinic No. 2
Full name of responsible person
Leila Nikrooz, Mr. Posesh, Ms Eftekhari
Street address
Mofatteh Clinic shahid No. 2, Yasuj, Kohgiluyeh and Boyer Ahmad
City
Yasuj
2
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Street address
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Mr. Mehdi Akbar Tabar
Street address
Yasuj University of Medical Sciences, Yasuj, Kohgiluyeh and Boyer Ahmad Province
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Leila Nikrooz
Position
Instructor, School of Nursing and Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Yasuj University of Medical Sciences, Yasuj, Kohgiluyeh and Boyer Ahmad
City
Yasuj
Postal code
Phone
+98 74 1223 3705
Fax
Email
lnikrooz@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Hesamodin Nabavi zadeh
Position
Specialty Asthma and Immunology
Other areas of specialty/work
Street address
Yasuj University of Medical Sciences, Yasuj, Kohgiluyeh and Boyer Ahmad Province
City
Yasuj
Postal code
Phone
+98 91711108767
Fax
Email
drhesamnabavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Leila Nikrooz
Position
Faculty member, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)