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IRCT20120718010333N4 IRCT 2019-01-08 Kashan University of Medical Sciences The effect of dietary phosphorus reduction on urine protein excretion Comparison of the effect of phosphorus-restricted diet with control diet on urine protein excretion in patients with proteinuria 2019-02-04 anticipated 90 Complete https://irct.ir/trial/33597 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups Participants were randomly assigned to intervention or control group in the random blocks based on the random number table.The sequence of permuted blocks was generated with a random number table. An individual with no clinical involvement in the trial, put the lable of intervention or control group in an opaque and sealed envelope based on the random sequence. Then the other person, who was not aware of random sequences and the envelope content, assigned the patients to the intervention or control group. N/A Proteinuria. Intervention 1: Intervention group: A diet will be designed and recommended to intervention group that its phosphorus content will be limited to 10 to 12 mg/kg/day. The intervention duration will be 8 weeks. Also, the intervention group will receive nutritional education in terms of knowing dietary sources of phosphorus and the strategies to reduce their consumption. Intervention 2: Control group: For control group, a diet will be designed that its contents of energy and other macronutrients are completely similar to those of the intervention group, however, it is not limited in terms of phosphorus content. The intervention duration will be 8 weeks. Yes - There is a plan to make this available What will be shared: A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared. When: The start of the data access period will be one year after the publication of the results. To whom: Researchers working in academic institutions Conditions: In order to conduct meta analysis studies Where to obtain: Nasrin Sharifi, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608 How to obtain: An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request. Comments:
public Negar Mozaffari Rad
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 88715973474 +98 31 5554 0021 negar_mozaffari@yahoo.com Kashan University of Medical Sciences scientific Nasrin Sharifi
Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd.
Kashan Iran (Islamic Republic of) 88715973474 +98 31 5554 0021 sharifi-na@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with proteinuria in whom the ratio of protein to creatinine in a sample of urine is greater than 0.3 mg/mg The glomerular filtration rate (eGFR) should be greater than 15 mL/min/1.73 m2 The systolic blood pressure should be less than 150 mmHg The serum level of phosphorus should be more than 3 mg/dL Dietary intake of phosphorus should be more than 17-20 mg/kg/day Patients in whom at least 3 months have passed from the onset of anti-proteinuric medications use Patients with proteinuria and diabetes in whom at least 3 months have passed from the onset of taking the glucose lowering drugs or insulin The amount of medications consumed should be constant within 3 months before the start of the study and their type and dosage do not change during the intervention 18 years 70 years Both Pregnancy Lactation Patients with urinary tract infections Patients with pyelonephritis Patients with kidney stones consumption of various kind of phosphate binders Taking calcium and vitamin D supplements within 3 months before the start of the study R80.1 Persistent proteinuria, unspecified Treatment - Other Treatment - Other Intervention group: A diet will be designed and recommended to intervention group that its phosphorus content will be limited to 10 to 12 mg/kg/day. The intervention duration will be 8 weeks. Also, the intervention group will receive nutritional education in terms of knowing dietary sources of phosphorus and the strategies to reduce their consumption. Control group: For control group, a diet will be designed that its contents of energy and other macronutrients are completely similar to those of the intervention group, however, it is not limited in terms of phosphorus content. The intervention duration will be 8 weeks. A change in urine protein to creatinine ratio. Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum level of phosphorus. Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit and analyzer instrument. Urine levels of phosphorus. Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit. Serum level of fibroblast growth factor 23 (FGF23). Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit and analyzer instrument. A change in glomerular filtration rate (eGFR). Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: CKD-EPI formula. Serum levels of creatinine. Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit and analyzer instrument. Serum levels of uric acid. Timepoint: At baseline and 8 weeks after the start of the phosphorus restricted diet or control diet. Method of measurement: Laboratory clinical kit and analyzer instrument. Kashan University of Medical Sciences Approved 2018-11-05 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Pezeshk Ave., Qotb-e-Ravandi Blvd. Kashan Isfehan Iran (Islamic Republic of)