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IRCT20090822002365N29 IRCT 2023-08-05 Iran University of Medical Sciences effect of vitamin D and vitamin C in patients with acute respiratory failure 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 2023-08-06 anticipated 64 Complete https://irct.ir/trial/71527 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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 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. 3 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).. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: 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: Known researchers from prestigious academic research centers. Conditions: 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. Where to obtain: Direct contact with the email address or phone number of the responsible author or the administrators of this research project. How to obtain: 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. Comments:
public Mohammad Reza Vafa
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 rezavafa@yahoo.com Iran University of Medical Sciences scientific Mohammad Reza Vafa
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4734 rezavafa@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 85 years Both 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. J96.0 Acute respiratory failure N/A N/A 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. 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. 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. The duration of connection to the ventilator. Timepoint: the end of the study. Method of measurement: From the patient's file. The duration of connection to the ventilator. Timepoint: 28th and 90th day of study. Method of measurement: From the patient's file. Iran University of Medical Sciences Approved 2023-06-13 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran تهران Tehran Iran (Islamic Republic of)