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IRCT20200720048139N1 IRCT 2020-11-09 Islamic Azad University Investigating effect of Spirulina dietary supplementation on COVID-19 disease outcomes in patients admitted to Intensive Care Units Investigating effect of Spirulina (Arthrospira platensis) dietary supplementation on COVID-19 disease outcomes in patients admitted to Intensive Care Units of hospitals: phase 2 clinical trial 2020-11-21 anticipated 138 Complete https://irct.ir/trial/51784 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, we have an intervention group and a control group. Intervention group will receive 5 grams of spirulina supplement in addition to routine medications and control group will not receive anything other than routine medications, Randomization description: Simple randomization is used to identify samples in the control or intervention group. We will put 138 small envelopes containing random numbers obtained from the table of random numbers (69 evens and 69 odds) and the consent form inside a large envelope. The even numbers belong to the intervention group and odd numbers belong to the control group. The patient (if the patient is not conscious the person in private care of the patient) is asked to take one of the envelopes and will be placed in one of the control or intervention groups based on the number taken. 2 COVID-19. Intervention group: COVID-19 patients hospitalized in ICU. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Monireh Hatami
Faculty of Farmacy, Yakhchal Street, Shariati Street,
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2200 2040 mhnutr@gmail.com Islamic Azad University scientific Mahdi Shadnoush
Shahid Beheshti University of Medical Sciences, 7th Floo, Arabi Ave, Daneshjoo Blvd, Velenjak
Teran Iran (Islamic Republic of) 19839-63113 +98 21 2243 9798 mshadnoush@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) All covid-19 patients confirmed with PCR test admitted to the ICU are entered the trial 18 years no limit Both Age less than 18 Women during pregnancy and lactation Consumers of supplements C, E, Omega 3, Antioxidants in the last 3 months Patients with severe renal failure Patients with liver failure last stage (cirrhosis) Patients with uncontrolled hypertension Patients who do not have a functioning gastrointestinal tract and have not been prescribed oral or intravenous nutrition Patients with drug / food allergies U07.1 بیماری کووید-19 تایید شده با تستهای آزمایشگاهی Treatment - Other Intervention group: COVID-19 patients hospitalized in ICU IL6. Timepoint: The first and 28th of the study. Method of measurement: Blood Sample method: ELISA ; sensivity 0.06 pg/ml. ESR (Erythrocyte sedimentation rate). Timepoint: The first and 28th of the study. Method of measurement: Automated Modified Westergren. CRP. Timepoint: The first and 28th of the study. Method of measurement: Blood sampling- ELISA. Nutrition Status. Timepoint: the first and 28th of the study. Method of measurement: Nutric-score Questionnaire. Fever. Timepoint: Daily. Method of measurement: Digital Thermometer. O2 SATURATION. Timepoint: Duration the stay in ICU. Method of measurement: Pulse Oxymeter. Duration of Stay in ICU. Timepoint: Since the first day till end of stay in ICU. Method of measurement: OBSERVATION. Ventilator Free days. Timepoint: During the stay in ICU. Method of measurement: Observation. Mortality Rate. Timepoint: During the stay in ICU. Method of measurement: Observation. Islamic Azad University Approved 2020-06-07 Ethics Committee of Islamic Azad Tehran Medical Sciences University-Pharmacy and Pharmaceutical Bran Faculty of Pharmacy and Pharmaceutical Branches, Yakhchal Street, Shariati Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)