Protocol summary
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Study aim
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Evaluation of the effect of sweet almond capsule on function of kidney and quality of life in patients with chronic renal failure
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Design
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Patients with chronic kidney disease, stages 2 and 3, who visited Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
Sample size: 60 people
Clinical trial with control group, double-blind, randomized, phase 2 on 60 patients
Randomization: Random Number Table
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Settings and conduct
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Location: Shahrvand Kidney subspecialty clinic and Baghban clinic of Sari
For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with chronic kidney disease stage 2 and 3, Age range 18 to 75 years
Exclusion criteria: clinically unstable, malignancy, Heart Failure, previous diagnosis of primary hyperoxaluria, History of calcium oxalate kidney stone, Known allergy to almond, Liver failure, Pregnancy, Inability to communicate, Polycystic kidney disease, acute infectious disease
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Intervention groups
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Intervention group will receive capsules, containing 350 mg of almond, twice a day. Control group will receive placebo capsules exactly according to the original medication, twice a day. Both groups are treated for 8 weeks.
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Main outcome variables
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Glomerular filtration rate
Serum creatinine
Blood Urea Nitrogen
24-hour urine protein
Serum Albumin
Serum uric acid
Serum potassium
Blood pressure
Hemoglobin
Serum C-Reactive Protein (CRP)
Lipid profile
Fasting blood sugar
Quality of Life
General information
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Reason for update
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Changing age of patients
Completion of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200516047465N1
Registration date:
2020-08-09, 1399/05/19
Registration timing:
prospective
Last update:
2023-07-18, 1402/04/27
Update count:
1
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Registration date
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2020-08-09, 1399/05/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-08-05, 1399/05/15
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Expected recruitment end date
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2021-01-04, 1399/10/15
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Actual recruitment start date
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2021-01-20, 1399/11/01
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Actual recruitment end date
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2021-12-06, 1400/09/15
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Trial completion date
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2021-12-06, 1400/09/15
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Scientific title
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Evaluation of the effect of sweet almond capsule on function of kidney and quality of life in patients with chronic renal failure
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Public title
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The effect of sweet almond on chronic renal failure
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with chronic kidney disease stage 2 and 3
Age range 18 to 75 years
Exclusion criteria:
Clinically unstable
Malignancy
Heart Failure
Previous diagnosis of primary hyperoxaluria
History of calcium oxalate kidney stone
Known allergy to almond
Liver failure
Pregnancy
Inability to communicate
Polycystic kidney disease
Acute infectious disease
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For randomization, a quadruple block randomization method is used. In this method, all permutations obtained from 2 groups are calculated as follows:
1) AABB 2) ABAB 3) ABBA 4) BABA 5) BAAB 6) BBAA
Among them, using random number table, we will select samples in the following order.
The selected permutation:
3, 1, 4, 5, 2, 6, 3, 1, 2, 5, 6, 4, 1, 6, 3
A is the intervention group and B is the control group. The advantage of this method is that the groups are equal.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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For blinding, the patient and attending physician responsible for evaluating patients and also the researcher will be unaware of the type of treatment for each group (drug or placebo). For this purpose, after randomization and division of patients into two groups, the drug and placebo are separated by code A or B, and then they are labled by the statistical consultant. In this way, the patient, the attending physician, and the researcher will not be aware of the type of treatment.
Drug and placebo are similar in appearance, color and smell.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-27, 1399/02/08
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Ethics committee reference number
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IR.MAZUMS.REC.1399.128
Health conditions studied
1
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Description of health condition studied
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Chronic kidney disease, stage 2
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ICD-10 code
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N18.2
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ICD-10 code description
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Chronic kidney disease, stage 2
2
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Description of health condition studied
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Chronic kidney disease, stage 3
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ICD-10 code
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N18.3
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ICD-10 code description
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Chronic kidney disease, stage 3
Primary outcomes
1
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Description
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Glomerular filtration rate
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Timepoint
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Before and after the intervention
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Method of measurement
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Modification of Diet in Renal Disease (MDRD) formula
Secondary outcomes
1
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Description
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Serum creatinine
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
2
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Description
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Blood Urea Nitrogen
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
3
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Description
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24-hour urine protein
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Timepoint
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before and after the intervention
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Method of measurement
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24-hour urine evaluation
4
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Description
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Serum Albumin
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
5
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Description
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Serum uric acid
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
6
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Description
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Serum potassium
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
7
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Description
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Blood pressure
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Timepoint
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before and after the intervention
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Method of measurement
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Sphygmomanometer
8
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Description
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Hemoglobin
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
9
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Description
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Serum C-Reactive Protein (CRP)
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
10
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Description
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Lipid profile
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
11
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Description
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Fasting blood sugar
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Timepoint
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before and after the intervention
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Method of measurement
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Laboratory blood test
12
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Description
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Quality of Life
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Timepoint
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before and after the intervention
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Method of measurement
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The Short Form (36) Health Survey (SF-36)
Intervention groups
1
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Description
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The drug is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Intervention group will receive capsules, containing 350 mg of almond, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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The placebo is made in faculty of pharmacy, Shahid Beheshti University of Medical Sciences. Control group will receive placebo capsules exactly according to the original medication, twice a day; 30minutes before breakfast and 30 minutes before dinner. Both groups are treated for 8 weeks.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Laboratory information
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When the data will become available and for how long
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Four months after printing the results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Researchers working in academic and scientific institutions
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From where data/document is obtainable
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s.meghdadi@mazums.ac.ir
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What processes are involved for a request to access data/document
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Email to the researcher
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Comments
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