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IRCT20190415043279N11 IRCT 2022-03-07 Sanandaj University of Medical Sciences Evaluation of the effect of probiotic supplementation on the proteinuria Evaluation of the effect of probiotic supplementation on the improvement of proteinuria in patients with immunoglobulin A nephropathy 2022-04-04 anticipated 120 Complete https://irct.ir/trial/62209 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Probiotic Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients, Blinding description: All supplements and placebo capsules were identical with respect to appearance and only differed in coding of the capsules. The treatment code of the intervention supplements was blinded for subjects, investigators and staff involved in the conduct of the study. 3 IgA nephropathy. Intervention 1: Intervention group: Omega 3 capsules 1000 mg and Valsartan in addition to probiotic capsules of Milad Pouya Company Probiotic Capsules, approved by the US Food and Drug Administration and under the brand name Prodigest, are taken once a day for six months. Intervention 2: Control group: Omega 3 capsules 1000 mg, Valsartan plus placebo are taken as one capsule once a day for six months. 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 No more information
public Dr Mohammad saad Forghani
Tohid Hospital, Tohid Blvd
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 drforghani@yahoo.com Sanandaj University of Medical Sciences scientific Dr Mohammad saad Forghani
Tohid Hospital, Tohid Blvd
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4645 drforghani7791@yahoo.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Early IgA nephropathy diagnosed by biopsy Albuminuria more than 0.75 grams per day Serum creatinine less than 200 micromoles per liter Creatinine clearance greater than 30 ml per minute 18 years no limit Both Inflammatory diseases Diabetes Celiac Cancer AIDS Autoimmune diseases Pregnancy Breastfeeding Secondary IgA nephropathy Allergy to probiotics E08.21 Diabetes mellitus due to underlying condition with diabetic nephropathy Placebo Placebo Intervention group: Omega 3 capsules 1000 mg and Valsartan in addition to probiotic capsules of Milad Pouya Company Probiotic Capsules, approved by the US Food and Drug Administration and under the brand name Prodigest, are taken once a day for six months. Control group: Omega 3 capsules 1000 mg, Valsartan plus placebo are taken as one capsule once a day for six months Body Mass Index (BMI). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: by measuring height and weight using a scale and height meter. 24-hour urinary protein level. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: laboratory kit. Duration of illness. Timepoint: Examination by a nephrologist once every two months until the end of the 6-month period (three times). Method of measurement: Patient file. Side effects. Timepoint: Periodically every month until the end of 6 months. Method of measurement: Telephone contact with patients. Sanandaj University of Medical Sciences Approved 2021-12-21 Ethics committee of Kurdistan University of Medical Sciences Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran Sanandaj Kurdistan Iran (Islamic Republic of)