Effect of supplementation of vitamin D, C and E on the lung functional tests, level of hs-CRP, ESR, TGFβ1 and antioxidant status in Idiopathic Pulmonary Fibrosis patients
This study carried out in patient with pulmonary fibrosis and the aim of it is finding the effect of supplementation of vitamin E, C and D on lung tissue and its function moreover evaluating changes in biomedical and inflammatory factors. Patients with pulmonary fibrosis who passed more than six months of their disease and are not using another supplements will be enrolled in the study. If supplement consumption be less than 80% or having unwillingness to continue the participation they will be excluded from the study. The number of participants are 36 persons, in one group for intervention. Who will get daily dose of 200 IU of vitamin E, 250 mg of vitamin C for every other day for 12weeks, and weekly 50000 IU dose of vitamin D for 8 weeks and one another for 12th week. Pulmonary tests will evaluate lung functions, for measurement of forced expiratory volume in the first second as a primary outcome and also forced vital capacity, total lung capacity, inspiratory and expiratory reserve volume will be dumped for lung function assessment. Inflammatory parameters like Erythrocyte sedimentation rate, concentration of High-sensitivity c-reactive protein and Transforming growth factor β1 will be measured. As well as antioxidant factors such as glutathione peroxidase and concentration of protein carbonyl will be examined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612202365N15
Registration date:2017-01-07, 1395/10/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-07, 1395/10/18
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
Iran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplementation of vitamin D, C and E on the lung functional tests, level of hs-CRP, ESR, TGFβ1 and antioxidant status in Idiopathic Pulmonary Fibrosis patients
Public title
Effect of vitamin supplementation on pulmonary fibrosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Adults (20 years<) with idiopathic pulmonary fibrosis and according to the guidelines of Thoracic Society United States of America and Respiratory Health Association of Europe and final confirmation of respiratory disease physician, patients diagnosed for more than 6 months; Both sex; Avoiding the use of vitamin supplements Exclusion criteria: Unwillingness of individuals to continue participating in the study; Admission supplement inadequate (less than 80% of supplements)
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.IUMS.REC1395.9411323008
Health conditions studied
1
Description of health condition studied
pulmonary fibrosis
ICD-10 code
j84.1
ICD-10 code description
Other interstitial pulmonary diseases with fibrosis
Primary outcomes
1
Description
percent of Forced Exspiratory Volume in First Second FEV1
Timepoint
before intervention and 3 month after starting the intervention
Method of measurement
spirometry
Secondary outcomes
1
Description
Transforming growth factor β1
Timepoint
Before intervention and 3 month after intervention
Method of measurement
measurement kit
2
Description
Inspiratory Reserve volume
Timepoint
Before intervention and 3 month after intervention
Method of measurement
spirometry
3
Description
Expiratory Reserve Volume
Timepoint
Before intervention and 3 month after intervention
Method of measurement
spirometry
4
Description
Protein carbonyls
Timepoint
Before intervention and 3 month after intervention
Method of measurement
measurement kit
5
Description
Residual Volume
Timepoint
Before intervention and 3 month after intervention
Method of measurement
spirometry
6
Description
Tidal Volume
Timepoint
Before intervention and 3 month after intervention
Method of measurement
spirometry
7
Description
High-sensitivity c-reactive protein
Timepoint
Before intervention and 3 month after intervention
Method of measurement
measurement kit
8
Description
Erythrocyte sedimentation rate
Timepoint
Before intervention and 3 month after intervention
Method of measurement
measurement kit
Intervention groups
1
Description
Participants will get a daily supplement of vitamin E with 200 IU dosage, vitamin C supplement with 250 mg dose every other day and 50000 IU of vitamin D once a week and for 8 weeks and another one in 12th week of study
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza 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
Mohammadreza Vafa
Position
Professor
Other areas of specialty/work
Street address
Nutrition Department, Health Faculty, Iran University of Medical Sciences, Beside Milad tower, Shahid Hemat Highway, Tehran, Iran
City
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Fax
Email
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
Mohammadreza Vafa
Position
PhD
Other areas of specialty/work
Street address
Nutrition Department, Health Faculty, Iran University of Medical Sciences, Beside Milad tower, Shahid Hemat highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 4743
Fax
Email
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
Mahsa Yavari
Position
Master student
Other areas of specialty/work
Street address
Health faculty, Iran University of Medical Sciences, Beside Milad Tower, Shahid Hemat Highway, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8828 5277
Fax
Email
mahsayavari.nut@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)