Protocol summary

Study aim
In this study, the effect of magnesium citrate on COVID-19 will be examined.
Design
A clinical trial with control group including a sample size of 60 people,with parallel group, double-blind, randomized
Settings and conduct
This study is a randomized, double-blind, placebo-controlled trial, which the researcher and participants will be blinded by encoding magnesium citrate and placebo by the other person. The subjects are hospitalized patients with COVID-19 at Razi hospital in Ahvaz, which will have the inclusion criteria to enter the study. The participants will be randomized through the statistical method of permuted block. Blocks will be determined using statistical software.
Participants/Inclusion and exclusion criteria
Patients aged 18 to 65 years ؛ Laboratory confirmation of Covid-19 (2019-nCoV Real-Time RT-PCR)
Intervention groups
Patients in both groups receive the treatment based on the Covid-19 National Guidelines. Patients in the intervention group, in addition to the standard treatment protocol, receive magnesium citrate supplement in the form of 300 mg capsules once a day for 1 month. And the control group also receives placebo containing starch according to the above method.
Main outcome variables
Cough ؛ Oxygen saturation ؛ Respiratory rate ؛ Fever ؛ Rate of lung involvement ؛ Duration of hospitalization ؛ hs-CRP ؛ TNF-α ؛ CBC ؛ Final status of the patient ؛ Depression ؛ Anxiety ؛ Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210413050957N1
Registration date: 2021-05-01, 1400/02/11
Registration timing: prospective

Last update: 2021-05-01, 1400/02/11
Update count: 0
Registration date
2021-05-01, 1400/02/11
Registrant information
Name
Sepideh Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3441 2049
Email address
sepidehrostami.nutrition@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of magnesium citrate supplementation on clinical symptoms and TNF-α and hs-CRP factors in patients with COVID-19
Public title
Survey the effect of magnesium citrate supplementation on clinical symptoms and TNF-α and hs-CRP factors in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Laboratory confirmation of Covid-19 (2019-nCoV Real-Time RT-PCR) Patients with moderate status Age from 18 to 65 years gender: male/female
Exclusion criteria:
Hospitalization of the patient in the intensive care unit Underlying diseases such as diabetes, hypertension, cardiovascular disease, kidney disease and mental disorders such as depression Obesity (BMI ≥ 30) Vitamin D level less than 30 ng / ml Hypomagnesemia (magnesium level less than 1.7 mg / dL) and hypermagnesemia (magnesium level higher than 2.6 mg / dL) Pregnancy and lactation Contraindications, intolerance or allergy to magnesium Taking dietary supplements Alcohol and drug abuse
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to individuals is random and the randomized permutation blocks with block size 4 (using the table related to random permutations). The randomization list is prepared by a statistician. The supplement and placebo used in this study, according to the randomized list, will be placed in closed envelopes by a person outside the study who does not know the research objectives and according to the corresponding codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and participants are blinded by coding the drug in the form of A and B, so that someone else is asked to encode the magnesium citrate and placebo to A and B which are similar in appearance. The participants and the researcher will be uninformed of the type of intervention. As a result, the study will be performed in the forms of double blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.AJUMS.REC.1400.025

Health conditions studied

1

Description of health condition studied
covid-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified.

Primary outcomes

1

Description
Cough
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination

2

Description
Oxygen saturation
Timepoint
First and 30 days after the intervention
Method of measurement
using pulse oximeter device

3

Description
Respiratory rate
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination

4

Description
Fever
Timepoint
First and 30 days after the intervention
Method of measurement
Clinical examination

5

Description
Rate of lung involvement
Timepoint
First and 30 days after the intervention
Method of measurement
CT scan of the chest

6

Description
Duration of hospitalization
Timepoint
First and 30 days after the intervention
Method of measurement
Counting the days of hospitalization

7

Description
hs-CRP
Timepoint
First and 30 days after the intervention
Method of measurement
Based on laboratory measurements-mg/l

8

Description
TNF-α
Timepoint
First and 30 days after the intervention
Method of measurement
Based on laboratory measurements-mg/l

9

Description
CBC
Timepoint
First and 30 days after the intervention
Method of measurement
Cell counter

10

Description
Final status of the patient
Timepoint
First and 30 days after the intervention
Method of measurement
Dead / Alive

11

Description
Depression
Timepoint
First and 30 days after the intervention
Method of measurement
questionnaire scoring(BDI-II)

12

Description
Anxiety
Timepoint
First and 30 days after the intervention
Method of measurement
questionnaire scoring(STAI)

13

Description
Quality of Life
Timepoint
First and 30 days after the intervention
Method of measurement
questionnaire scoring(sf-36)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The magnesium citrate supplement is taken as a 300 mg capsule once a day for 1 month.
Category
Treatment - Drugs

2

Description
Control group: The placebo is taken as a capsule containing 300 mg starch once a day for 1 month.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Sepideh Rostami
Street address
Felestin Ave., Amanieh Town
City
ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5937
Email
sepidehrostami.nutrition@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehdi Ahmadi Moghadam
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sepideh Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 32, Ershard Blvd., Kooye Naft Town
City
Ahvaz
Province
Khouzestan
Postal code
6166673797
Phone
+98 61 3441 2049
Fax
Email
sepidehrostami.nutrition@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sepideh Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 32, Ershard Blvd., Kooye Naft Town
City
Ahvaz
Province
Khouzestan
Postal code
6166673797
Phone
+98 61 3441 2049
Fax
Email
sepidehrostami.nutrition@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sepideh Rostami
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No. 32, Ershard Blvd., Kooye Naft Town
City
Ahvaz
Province
Khouzestan
Postal code
6166673797
Phone
+98 61 3441 2049
Fax
Email
sepidehrostami.nutrition@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...