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IRCT20100223003408N6 IRCT 2020-02-09 Shiraz University of Medical Sciences Randomized clinical trial Randomized clinical trial effect of diet therapy and nutrition education on clinical indicators, malnutrition, depression and quality of life in chronic kidney disease patients referred to Motahari clinic and Faghihi Hospital of Shiraz in 1398 2019-06-22 anticipated 120 Complete https://irct.ir/trial/45108 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Block randomization, Individual, Random allocation software, 11 randomization sequence in permuted blocks of size 4 In this study, the allocation of people to the two groups was done using permutational block method. In this method, T represents the person who receives the intervention, and C represents the person who is in the control group. Considering the quadruple block; we achieved TTCC , TCCT , CTTC , TCCT , CCTT , TCCT , TCTC , TCCT , CCTT , TCTC and TTCC . Then, using the randomization software and sealed envelopes we allocate each one to a patient respectively. 3 chronic kidney disease. Intervention 1: Intervention group:direct education based on chronpoic kidney disease diet .the intervention is carried through education aid such as powerpoint(and CKD diet,nutrition counseling,diet tip s,exchange list) through 1-2hours sessions twice in 6 month.indirect education has been done by booklet. and also especial type of diet according to pre dialysis based on blood sample ,weight and hight and patients followed.educational and diet therapy in case done during 24-week. Intervention 2: Control group: this group are educated about routin nutrition and diet during 24_ week by nephrologist. 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 further information
public Maryam Ekramzade
Razi Blvd.
shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 m_ekramzade@yahoo.com Shiraz University of Medical Sciences scientific Maryam Ekramzade
Razi Blvd.
Shiraz Iran (Islamic Republic of) 71536-75541 +98 71 3725 1001 m_ekramzade@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) The dosage of medications taken during the past six months did not change during the study Willing to participate in the study and have written consent GFR between 15 and 60 Adults between 18-65 years 18 years 65 years Both Has malignancy AIDS , acute or inflammatory infection , diabetes patient , cancer patients , decompensated HF patient, renal transplant recipients , dialysis patients , Alzheimer's patients , patients Cognitive problems, patients with mental illness , pregnant patients or those who plan to be pregnant during the study period , the patient's death during the study , the patient's unwillingness to participate and participate in training sessions , the participant with motor impairment (weakness) Musculoskeletal), treatment regimen over the past month , loss of inclusion criteria decline GFR N18.3 Chronic kidney disease, stage 3 (moderate) Lifestyle Treatment - Other Intervention group:direct education based on chronpoic kidney disease diet .the intervention is carried through education aid such as powerpoint(and CKD diet,nutrition counseling,diet tip s,exchange list) through 1-2hours sessions twice in 6 month.indirect education has been done by booklet. and also especial type of diet according to pre dialysis based on blood sample ,weight and hight and patients followed.educational and diet therapy in case done during 24-week Control group: this group are educated about routin nutrition and diet during 24_ week by nephrologist EGFR. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: formula. BUN. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Cratinine. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Albumin. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Calcium. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Sodium. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Phosphor. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Potasium. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Hemoglobin. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Uric acid. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Hematocrit. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Autoanalyser. Weight. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: scale. BMI. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: Formula. Subjective global assessment. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: questionnaire. Quality of Life. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: questionnaire. Depression. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: questionnaire. Parathyroid hormone. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: autoanalyser. Feritin. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition training. Method of measurement: ELISA. Vitamin D. Timepoint: At the beginning of the study (before the intervention) and six months after the start of treatment and nutrition. Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2019-06-22 Ethics committee of Shiraz University of Medical Sciences Zand street Shiraz University of Medical Sciences shiraz Fars Iran (Islamic Republic of)