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IRCT20190206042644N1 IRCT 2019-03-11 Arak University of Medical Sciences The Role of Vitamin D Supplements on Pulmonary Hypertension in Patients with Thalassemia Evaluation of the Role of Vitamin D Supplements on Pulmonary Hypertension in Patients with Thalassemia Major and Intermedia 2018-10-23 anticipated 28 Complete https://irct.ir/trial/37538 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, using the random sequence numbers obtained from https://www.random.org/. In this way, each person is assigned a number from 1 to 28, then from the site, two random groups are obtained from numbers 1 to 28, the first group as the intervention group and the second group is considered as the control group. 3 Condition 1: Pulmonary Hypertension. Condition 2: Thalassemia. Intervention 1: Intervention group: Individuals in this Group are treated with Oral Vitamin D, at a dose of 500,000 units per week, for 20 weeks. Intervention 2: Control group: People in this Group will not receive any Medication and Intervention. Yes - There is a plan to make this available What will be shared: Data of Participants in this Study, which will be shared after being unidentified, include Age, Sex, Serum Levels of Vitamin D before and after intervention, and Pulmonary Arterial Pressure before and after intervention. When: The beginning of the Data Access Period for this Study will be One year after the Results are Published, and these Data are available for 2 years. To whom: This data will be accessible to researchers and students working in universities and research centers who intend to conduct supplementary studies or studies similar to this research. Conditions: Use of data to carry out any kind of study and analysis is allowed by mentioning source. Where to obtain: To access this data, contact one of the following ways, with "Fatemeh Fadayi" contributor: 1. Phone No.: 0098 935 0246 2. Email: Shaqayeqfadayi@gmail.com How to obtain: A ready-made file of shareable data will be provided, and applicants for data access, will receive the data as soon as possible after they have introduced their goal to access the data. Comments:
public Fatemeh Fadayi
Abolmasumi Deadend, A'lamolhoda Blvd
Arak Iran (Islamic Republic of) 3819717575 +98 26 3420 4232 shaqayeqfadayi@gmail.com Arak University of Medical Sciences scientific Fatemeh Fadayi
Abolmasumi Deadend, A'lamolhoda Blvd
Arak Iran (Islamic Republic of) 3819717575 +98 26 3420 4232 shaqayeqfadayi@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Parental Informed Consent Patients with Thalassemia Major under Regular Transfusion and Regular Chelation. Patients with Thalassemia Intermedia who do not have Regular Transfusion. no limit no limit Both Parental Dissatisfaction for Participation in the Study Congenital and Non-congenital Heart Disease Endocrine Disease such as Diabetes, Hypoparathyroidism and Hypothyroidism I27.0 D56.1 Primary pulmonary hypertension Beta thalassemia Prevention N/A Intervention group: Individuals in this Group are treated with Oral Vitamin D, at a dose of 500,000 units per week, for 20 weeks. Control group: People in this Group will not receive any Medication and Intervention. Pulmonary Hypertension. Timepoint: Measurement of Pulmonary Arterial Pressure at the Beginning of the Study (After Entering the Study and Before the Onset of the Intervention) and Repeat Measurements 6 months after Entry into the Study. Method of measurement: Echocardiography by Echocardiologist. Arak University of Medical Sciences Approved 2018-09-23 Ethics committee of Arak University of Medical Sciences Ethics committee of Arak University of Medical, Arak University of Medical Science, Basij Sq. Arak Markazi Iran (Islamic Republic of)