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IRCT20150909023957N9 IRCT 2021-06-20 Esfahan University of Medical Sciences effect of milk protein concentrate in AIDS Effect of Milk protein concentrate (MPC) supplementation on oxidative stress, immune function, quality of life and anthropometric measurements in patients with Acquired Immune Deficiency Syndrome; a double-blind randomized clinical trial 2021-06-22 anticipated 80 Complete https://irct.ir/trial/56905 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, 80 people were identified based on the sample size formula and after matching age and gender (with a 5-year interval) and will be randomly divided into two groups. Randomization will be done by PBR method. Using a reputable website to generate random numbers: https://www.sealedenvelope.com/simple-randomiser/v1/lists It will be done in a randomized block method and participants will be placed in one of two intervention groups or placebo. Patients will be divided into two groups based on random allocation, Blinding description: Both the placebo and supplement groups receive the same sachets in appearance and size that are inseparable except for the barcode. 3 HIV,AIDS. Intervention 1: Intervention group: Powder (condensed milk powder) MPC will receive 25 grams per day for 8 weeks. Intervention 2: Control group: They will receive 25 grams of Malto Dextrin sachet for 8 weeks. Yes - There is a plan to make this available What will be shared: In the case of data dissemination, it can be shared after identifying individuals, in the case of the study protocol, there is a decision to publish it before the articles are published, and a clinical study report will be published. When: Access period starts 6 months after the results are published To whom: For researchers working in universities and industrial research centers Conditions: The data will be delivered but their analysis or dissemination will no longer be allowed. Where to obtain: mohammad ali hojjati kermaniv,masih daneshvari hospital ,tehran,iran How to obtain: After receiving the request and review, the documents will be sent within 2 weeks if approved. Comments:
public payam tabarsi
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2000 p.tabarsi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Payam Tabarsi
Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran
tehran Iran (Islamic Republic of) 1956944413 +98 21 2712 2000 p.tabarsi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Willingness to cooperate with the project- CD4 level less than 500 - Patients with AIDS whose type of disease is fully confirmed through a complete medical examination and laboratory. Only patients with AIDS who have been on antiviral therapy for three months and are also on a consistent medication regimen should be included in this study. 18 years 45 years Both Use of protein supplements Drug useAlcohol, acetylcysteine, NSAIDs three months before the study Sensitivity to dairy products Do not take calcium supplements or any product containing it Drugs or supplements that affect the immune and inflammatory systems, such as antioxidants, sexing, omega 3, curcumin People who, in addition to AIDS, suffer from other diseases that have oxidative stress as their etiology. Including: metabolic syndrome, diabetic foot ulcer, coronary artery disease, lung infection. Patients with clinical conditions that pose a serious health risk, including severe kidney, liver, thyroid and parathyroid disease, gastrointestinal and heart disease and cancer B20 Human immunodeficiency virus [HIV] disease Other Placebo Intervention group: Powder (condensed milk powder) MPC will receive 25 grams per day for 8 weeks Control group: They will receive 25 grams of Malto Dextrin sachet for 8 weeks. Anthropometric evaluation. Timepoint: Beginning and end of the study. Method of measurement: Using tape measure and scales. Evaluation of safety indicators. Timepoint: Beginning and end of the study. Method of measurement: CD4, CD8 by flow cytometry. Evaluation of oxidative stress indices. Timepoint: Beginning and end of the study. Method of measurement: Evaluation of serum level of total antioxidant capacity (TAC) and total oxidative capacity (TOC) by Kiazist diagnostic kits. Evaluation of inflammatory indicators. Timepoint: Beginning and end of the study. Method of measurement: The inflammatory marker ESR is determined by sodium citrate anticoagulant and CRP by ELISA and commercial German LDN kit. Quality of Life. Timepoint: Beginning and end of the study. Method of measurement: Quality of Life Questionnaire through HIV Disability Questionnaire (HDQ). Evaluation of renal index. Timepoint: Beginning and end of the study. Method of measurement: Creatine test and BUN test are performed based on enzymatic method. Evaluation of protein index. Timepoint: Beginning and end of the study. Method of measurement: Albumin levels are measured based on the Bromocresol Green test. Shahid Beheshti University of Medical Sciences Esfahan University of Medical Sciences Shahid Beheshti University of Medical Sciences Approved 2021-05-26 Research Ethics Committees of Vice-Chancellor in Research Affairs -Medical University of Isfahan medical university of esfahan-hezarjerrib st esfahan Isfehan Iran (Islamic Republic of)