The effect of simultaneous supplementation of oral vitamin D and intravenous vitamin C on inflammatory indices, oxidative stress and clinical outcomes in patients with acute respiratory failure admitted to the intensive care unit
Determining the effect of simultaneous supplementation of oral vitamin D and intravenous vitamin C on inflammatory indices, oxidative stress and clinical outcomes in patients with acute respiratory failure admitted to the intensive care unit
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 64 patients. Blocks of 4 sites from the online site (www.sealedenvelope.com) will be used for randomization.
Settings and conduct
The study is conducted in a triple-blind manner in Firoozgar Hospital. The duration of the intervention is 5-10 days in the form of daily intake of 5000 international units of oral vitamin D supplement and 2000 mg of injectable vitamin C or placebo. At the beginning of the study, people with acute respiratory failure disease will be included in the study based on the definitive diagnosis of the doctor and based on the mentioned entry criteria and filling the informed consent form.
Participants/Inclusion and exclusion criteria
Inclusion criteria: hospitalization in the intensive care unit
Age above 18 years and less than 85 years
suffering from acute respiratory failure
exclusion criteria: Death or hospitalization of the patient less than 3 days from the start of the intervention
Creating contraindications for the administration of vitamin D and vitamin C according to the physician's opinion at the time of the study
Intervention groups
In the intervention group, patients will receive daily 5000 international units of vitamin D in the form of oral drops and 2000 mg of vitamin C in the serum. While the patients of the control group will receive the same oral drops of vitamin D and the same serum without vitamin C.
Main outcome variables
The concentration of interleukin 6 and the duration of connection to the ventilator
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090822002365N29
Registration date:2023-08-05, 1402/05/14
Registration timing:prospective
Last update:2023-08-05, 1402/05/14
Update count:0
Registration date
2023-08-05, 1402/05/14
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2024-03-05, 1402/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of simultaneous supplementation of oral vitamin D and intravenous vitamin C on inflammatory indices, oxidative stress and clinical outcomes in patients with acute respiratory failure admitted to the intensive care unit
Public title
effect of vitamin D and vitamin C in patients with acute respiratory failure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
hospitalized patients in the intensive care unit
suffering from acute respiratory failure (PaO2 ≤ 60 mmHg or PaCO2 > 45 mmHg)
not Suffering from a nervous system disease that prevents the patient from being separated from the mechanical ventilation device
not suffering from AIDS
not suffering from Liver failure
not Suffering from kidney diseases including nephrotic syndrome-
not suffering from gout
not being Pregnancy and breastfeeding
Vitamin D level below 50 ng/mL
not suffering from hypercalcemia (total calcium > 10.6 mg/dL)
not Suffering from hyperphosphatemia (> 1.45 mmol/liter)
not suffering from Tuberculosis
not suffering from sarcoidosis
not Passing more than 24 hours from the diagnosis of the disease to the time of entering the study
not participating in other interventional studies in the last 30 days
not consuming vitamin D and vitamin C supplements in the last 30 days
Exclusion criteria:
Death or hospitalization of the patient less than 3 days from the start of the intervention
Unwillingness to continue studying and cooperating in it
developing contraindications for the administration of vitamin D and vitamin C according to the opinion of the attending physician at the time of the study.
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
More than 1 sample in each individual
Number of samples in each individual:
32
one patient with with acute respiratory failure that admitted to the intensive care unit
Randomization (investigator's opinion)
Randomized
Randomization description
For randomized allocation performing, permuted block randomization will be used by blocks with size of 4. According to the sample size of 64subjects, 12 blocks will be generated using the online site (www.sealedenvelope.com). In order to allocation concealment in the randomized process, unique codes will be used on the vitamin d drop boxes ,serums containing vitamin c and placebo that is generated by the software. Participants will be entered into study based on the produced sequence. The vitamin d drop boxes ,serums containing vitamin c and placebo will be allocated to the nurses for administration with code on them. Therefore, participants and nurses will be unaware of the type of intervention that will receive, as well as the random sequence which will be hidden and unpredictable.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In order to performing the triple-blinded of study, before study beginning, the vitamin d drops boxes and placebo and serum with and without vitamin c can be provided by someone other than the researcher, and the placebo drops and serum without vitamin c in appearance are similar to the supplementation drops and serum. The researcher, patients, nurses and statistical analyzer are not be aware about the allocation of studied subjects in each group during the evaluation of the studied outcomes until the end of the intervention period, conducting experiments and date analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
تهران
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-06-13, 1402/03/23
Ethics committee reference number
IR.IUMS.REC.1402.210
Health conditions studied
1
Description of health condition studied
Acute respiratory failure (ARF) is defined as a condition in which the patient's arterial oxygen pressure (PaO2) is less than 60 mmHg and/or arterial carbon dioxide pressure (PaCO2) is more than 45 mmHg. This result occurs when the weakness of the respiratory system leads to the inability to transfer oxygen from the air to the blood or to remove carbon dioxide from the blood and transfer it to the surrounding air, and various mechanisms such as hypoventilation, diffusion disorder, shunt, ventilation mismatch Perfusion or a combination of the mentioned items play a role in its creation. Acute respiratory failure may be caused by several diseases, including pneumonia, chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome (ARDS), and congestive heart failure (CHF).
ICD-10 code
J96.0
ICD-10 code description
Acute respiratory failure
Primary outcomes
1
Description
interlukin6
Timepoint
The results are evaluated at the beginning of the study and at the end of the 10th da
Method of measurement
The level of interlukin6 in serum is with ELISA method
Secondary outcomes
1
Description
The duration of connection to the ventilator
Timepoint
the end of the study
Method of measurement
From the patient's file
2
Description
The duration of connection to the ventilator
Timepoint
28th and 90th day of study
Method of measurement
From the patient's file
Intervention groups
1
Description
Intervention group: This group will receive daily 5000 international units of vitamin D in the form of oral drops (5 cc oral drops) and 2000 mg of vitamin C intravenously in the serum.
Category
N/A
2
Description
Control group: This group will receive daily 5 cc of edible oil similar to vitamin D drops in terms of shape, color and smell as placebo. In addition, this group will receive daily serums similar to the intervention group but without vitamin C, which are completely similar to the serum containing vitamin C as placebo.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Vafa
Street address
Department of nutrition, School of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2721
Email
researchcouncil2021@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of public health, Iran university of medical sciences, Hemmat highway, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Email
vafa.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If there is a request to use the data of this study in a meta-analysis or systematic review, the primary and secondary results of this study will be provided to the requesters in the form of joint research.
When the data will become available and for how long
Since the publication of the article resulting from this study, it will be possible to make the data available for the next two years. This time will probably be from the end of 2024 to the end of 2026.
To whom data/document is available
Known researchers from prestigious academic research centers.
Under which criteria data/document could be used
If the intellectual rights of the providers of this research are preserved and the proposed research is aimed at the goals of the current study or solving the clinical problem of the target group of this study, there is a possibility of cooperation.
From where data/document is obtainable
Direct contact with the email address or phone number of the responsible author or the administrators of this research project.
What processes are involved for a request to access data/document
After the contact of the researchers, the process of accessing the data and conducting joint research with the requesters will be done for a maximum of two months.