Protocol summary

Summary
Objectives: The objective of this study was to examine the changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential arterial hypertension. Design: Single arm study on 48 subjects, not blinded, intervention with magnesium oral supplementation. Settings and conduct: The participants took magnesium-supplementation for one month at home and had their blood pressure and hemodynamic parameters measured in hospital settings before and after the intervention. The measurements were performed with sphygmomanometer and impedance cardiography. Participants: Patients with essential arterial hypertension, aged 24-65, with unchanged antihipertensive therapy for at least one month. The exclusion criteria were: renal diseases, gastrointestinal diseases, diabetes mellitus, diseases of adrenal, thyroid and parathyroid glands, angina pectoris, congestive heart failure, aortic coarctation, food and drugs allergy, pregnancy, lactation, myocardial infarction, coronary revascularisation, transitory ischemic attack, oral intake of magnesium supplements in the last one month. Intervention: Daily oral supplementation with 300 mg magnesium in the form of magnesium-oxide granules ("Magnezijum 300 Direkt" , Hermes Arzneimittel GmbH, Germany) during one month at home. Primary outcome measures: blood pressure; heart rate; thoracic fluid content (L/kOhm); stroke volume (the amount of pumped blood during each systole, mL); stroke index ( normalized for body surface area,mL/m2); cardiac output (minute volume of heart, L/min) ; cardiac index (normalized for body surface area, L/(min*m2); acceleration index (peak acceleration of blood flow in the aorta, 1/100/s2); left cardiac work index (normalized for body surface area, kg*m/m²); systemic vascular resistance index (normalized for body surface area, dyn*s*m2/cm5).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081535716N1
Registration date: 2017-09-22, 1396/06/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-22, 1396/06/31
Registrant information
Name
Nikolina Banjanin
Name of organization / entity
Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade
Country
Serbia and Montenegro
Phone
00381 11 3612 762
Email address
nikolina.banjanin@med.bg.ac.rs
Recruitment status
Recruitment complete
Funding source
None
Expected recruitment start date
2014-09-17, 1393/06/26
Expected recruitment end date
2014-11-21, 1393/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential arterial hypertension
Public title
Changes of blood pressure and hemodynamic parameters after oral magnesium supplementation in patients with essential arterial hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age 24-65; essential arterial hypertention; unchanged antihipertensive therapy for at least one month; Exclusion criteria: renal diseases, gastrointestinal diseases, diabetes mellitus, diseases od adrenal, thyroid and parathyroid glands, angina pectoris, congestive heart failure, aortic coarctation, food and drugs allergy, pregnancy, lactation, myocardial infarction, coronary revascularisation, transitory ischemic attack, oral intake of magnesium supplements in the last one month
Age
From 24 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
None

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, University of Belgrade
Street address
Dr Subotica 8
City
Belgrade
Postal code
11000
Approval date
2015-07-01, 1394/04/10
Ethics committee reference number
29/VII-16

2

Ethics committee
Name of ethics committee
Ethics Committee of the Clinical Center Of Serbia
Street address
Pasterova 2
City
Belgrade
Postal code
11000
Approval date
2014-09-16, 1393/06/25
Ethics committee reference number
1322/1

Health conditions studied

1

Description of health condition studied
Essential (primary) hypertension
ICD-10 code
I10
ICD-10 code description
High blood pressure, Hypertension (arterial)(benign)(essential)(malignant)(primary)(systemic)

Primary outcomes

1

Description
Blood pressure (mm Hg)
Timepoint
Before and after intervention
Method of measurement
Sphygmomanometer and Impedance cardiography

2

Description
Heart rate (beats per minute)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

3

Description
Thoracic fluid content (L/kOhm)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

4

Description
Stroke Volume (mL)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

5

Description
Stroke index (mL/m2)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

6

Description
Cardiac output (L/min)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

7

Description
Cardiac index (L/(min*m2)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

8

Description
Acceleration index (L/100/s2)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

9

Description
Left cardiac work index (kg*m/m²)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

10

Description
Systemic vascular resistance index (dyn*s*m2/cm5)
Timepoint
Before and after intervention
Method of measurement
Impedance cardiography

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Daily oral supplementation with 300 mg of magnesium in the form of magnesium-oxide granules ("Magnezijum 300 Direkt" Hermes Arzneimittel GmbH, Germany) during one month at home. The granules were dissolved in the mouth with no liquid.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The Multidisciplinary Center for Polyclinic Diagnostics , Assessment and Treatment of Blood Pressure
Full name of responsible person
Street address
City
Belgrade

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
-
Full name of responsible person
-
Street address
-
City
-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
-
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
Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade
Full name of responsible person
Nikolina Banjanin
Position
Teaching Assisstant/MD
Other areas of specialty/work
Street address
Dr Subotica 8
City
Belgrade
Province
Serbia
Postal code
Phone
00381113612762
Fax
Email
nikolina.banjanin@med.bg.ac.rs
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade
Full name of responsible person
Nikolina Banjanin
Position
Teaching Assisstant/MD
Other areas of specialty/work
Street address
Dr Subotica 8
City
Belgrade
Province
Serbia
Postal code
Phone
00 381 11 3612762
Fax
Email
nikolina.banjanin@med.bg.ac.rs
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Institute of Hygiene and Medical Ecology, Faculty of Medicine, University of Belgrade
Full name of responsible person
Nikolina Banjanin
Position
Teaching Assisstant/MD
Other areas of specialty/work
Street address
Dr Subotica 8
City
Belgrade
Province
Serbia
Postal code
11000
Phone
00381113612762
Fax
Email
nikoliina.banjanin@med.bg.ac.rs
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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