Pulmonary Hypertension is a life-threatening disease in which with progressive increase in pulmonary vascular resistance patients come down with Heart failure and progressive decreasing in cardiac out put and this condition will end up to death.There are several kind of medication to control the disease,but in the course of disease may patients affected by other condition that will deteriorate the condition.one of these conditions is vitamin D deficiency, in our research we will evaluate the effect of vitamin D replacement therapy on 36 patients of Pulmonary Hypertension, who have suffered of vitamin D deficiency.So patients with Vitamin D deficiency and Pulmonary Hypertension in age 20-65 years old will be included in our study and ones who deny our trial or experience some medical complications will be excluded.,we will start replacement therapy by Vitamin D and calcium and after normalization of it's plasma level we will compare exercise capacity,pulmonary artery pressure and plasma level of Pro-Brain natriuretic peptide in the patients with pre treatment's variables of their own.and finally by analyzing the data we are going to observe the effect of vitamin D deficiency and it's treatment on patient with pulmonary Hypertension.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013091713828N3
Registration date:2013-11-23, 1392/09/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Ahmad Mirdamadi
Name of organization / entity
Islamic Azad university ,Najafabad branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1223 8028
Email address
drsamirdamadi@pmd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University,Najafabad branch
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of vitamin D replacement on patients with pulmonary hypertension and vitamin D deficiency
Public title
Vitamin D replacement therapy in patients with pulmonary Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
History of Pulmonary Hypertension(Mean PAP more than 25mmHg by cardiac Catheterization);Presence of Vitamin D deficiency;Not using Vitamin D supplements before intervention;Patient's content
Exclusion Criteria:
Adverse reaction of medication during the intervention;Failing of patient to keep on the trial
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
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
Isfahan Medical University
Street address
Hezar jarib street-azadi square
City
Isafahan
Postal code
Approval date
2013-10-02, 1392/07/10
Ethics committee reference number
492030
Health conditions studied
1
Description of health condition studied
Pulmonary Hypertention
ICD-10 code
126-128
ICD-10 code description
Pulmonary heart disease and diseases of pulmonary circulation
Primary outcomes
1
Description
6 Minute Walk Test
Timepoint
Before intervention and also after normalization of plasma level of Vitamin D
Method of measurement
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
2
Description
Pro-BNP
Timepoint
Before intervention and also after normalization of plasma level of Vitamin D
Method of measurement
Chimiluminescence
3
Description
Pulmonary Artery Pressure
Timepoint
Before intervention and also after normalization of plasma level of Vitamin D
Method of measurement
By Echocardiography and if need Right Heart catheterization
Secondary outcomes
1
Description
Plasma level of Vitamin D
Timepoint
Before intervention and 3 months after treatment and if need 6 months later
Method of measurement
Chimiluminescence
Intervention groups
1
Description
In this study 36 known case of pulmonary hypertension that had confirmed by Right Heart Catheterization will enter the study.Entering the study is based on patient's content and presence of Vitamin D deficiency(plasma level of Vitamin less than 30 ng/ml).In the first step demographic information like age,sex and past history of Heart disease will be recorded.and then 6MWT,plasma level of Pro-BNP and Pulmonary artery pressure will be added.In the trial course 50.000 IU of Vitamin D will be prescribed weekly in addition to 1 pill of Calcicare( contains of 200 mg magnesium,8 mg zinc and 400 IU of vitamin D).After 3 months plasma level of vitamin D will be measured and if it is not in normal range the second course of treatment will be carried out. after normalization of plasma level of vitamin D reevaluation of patients will be started by measuring the 6MWT,plasma level of Pro-BNP and Pulmonary artery pressure.
At the end variables will be entered the analyzing software to analyze the data.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Shariati. Hospital
Full name of responsible person
Dr. Mirdamadi
Street address
Shariati street
City
Isfahan
2
Recruitment center
Name of recruitment center
Isfahan Hospital
Full name of responsible person
Dr. Mirdamadi
Street address
Sheikhbahei street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University,Najafabad branch,Isfahan
Full name of responsible person
Dr.Mirdamadi
Street address
Najafabad Islamic Azad University، Daneshgah blv
City
Najafabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University,Najafabad branch,Isfahan
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Najafabad
Full name of responsible person
Dr. Mirdamadi
Position
Assistant Professor of Medical School/Cardiologist,Fellowship of Echocardiography
Other areas of specialty/work
Street address
Najafabad Islamic Azad University، Daneshgah blv
City
Najafabad
Postal code
Phone
+98 31 1223 8028
Fax
+98 31 1223 8028
Email
Drsamirdamadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Najafabad
Full name of responsible person
Dr. Mirdamadi
Position
Assistant Professor of Medical School/Cardiologist,Fellowship of Echocardiography
Other areas of specialty/work
Street address
Najafabad Islamic Azad University، Daneshgah blv
City
Najafabad
Postal code
Phone
+98 31 1223 8028
Fax
+98 31 1223 8028
Email
Drsamirdamadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)