The aim of this study is to compare the distance during 6 minute walk test before and after vitamin D replacement. Stable COPD outpatients with vitamin D deficiency or insufficiency will enter the study.Those with renal failure,kidney stone,hyper parathyroidism,advanced musculo -skeletal and degenerative joint disorders with inability to walk,peripheral vascular disease,Pulmonary artery pressure more than 50mmHg,left ventricular ejection fraction of less than 40%,and admission for COPD exacerbation within previous 2 weeks will be excluded.
Twenty five COPD outpatients will be studied.The distance during 6 minute walk test will be measured at presentation.They will receive Vitamin D pearls 50,000 IU weekly for 6 weeks .After 3 months, the second 6 minute walk test will be done and the maximum distance and during the test will be compared with those of the first test.Pulmonary function test are also measured before and three month after the intervention. To be assured from intestinal absorption of oral vitamin D,serum 25 hydroxy vitamin D and 24 hour urinay calcium excretion will be measured after 2 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021012419N1
Registration date:2013-04-20, 1392/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-20, 1392/01/31
Registrant information
Name
Mehrnaz Asadi Gharabaghi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61192646
Email address
asadi_m@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin D replacement on the distance during six minute walk test in patients with COPD
Public title
The effect of vitamin D replacement on overall physical performance of patients with chronic lung disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Outpatients with COPD and Vitamin D deficiency or insufficiency
Exclusion criteria:Chronic renal failure,Urolithiasis,Parathyroid disease,Peripheral vascular disease,Inability to walk because of neuromuscular or advanced degenerative joint disease;Pulmonary artery pressure more than 50 mmHg,Left ventricular ejection fraction less than 40% ,admission for COPD exacerbation within previous 2 weeks
Age
From 40 years old to 84 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Tehran University of Medical Sciences
Street address
Central official building,Ghods Street,Keshavarz Boulvard