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Effect of specific diet in treatment of patients with persistent microscopic hematuria

Protocol summary

Study aim
Effect of specific diet in treatment of patients with persistent microscopic hematuria
Design
All patients from 6 months to 16 years of age who are referred to the nephrology clinic with diagnosis of isolated asymptomatic microscopic hematuria without a specific cause and any treatment will enrolled in this study. Patiets will divided into two groups.We will start hypoallergenic diet in group I (study group), and no diet in group II (control group) (usually these patients with asymptomatic microscopic hematuria will be followed with no treatment). Urinalysis for evaluation of RBC number will be evaluate after a while in both groups. (In this study we do not have any intervention in control group, and just follow them in usuall situation).
Settings and conduct
Assessment of a child with hematuria is performed at Mofid hospital with a detailed history, physical examination, and simple urine analysis.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients 6 month to 16 years with isolated microscopic hematuria without a definite stable causes exclusion criteria Patients with upper urinary tract disease (including glomerular diseases such as IgA nephropathy, thin basal membrane disease, Alport syndrome, post-infection glomerulonephritis, nephropathy mammrano) , uremic hemolytic syndrome, sickle cell disease, and interstitial disease like pyelonephritis, interstitial nephritis , Papillary necrosis and acute tubular necrosis and vascular diseases and anatomical causes such as hydronephrosis, cystic kidney disease, tumor and trauma). factitious hematuria.
Intervention groups
Assessment of patients is done by taking a history and urinalysis. The patients will divide into two groups. The first group is on a hypoallergenic diet and the second group (control group) will receive no intervention. We have no drug intervention in this study.
Main outcome variables
urinary RBC

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191230045940N1
Registration date: 2020-10-07, 1399/07/16
Registration timing: retrospective

Last update: 2020-10-07, 1399/07/16
Update count: 0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Masoumeh Mohkam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 9658
Email address
mohkam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-04-21, 1397/02/01
Actual recruitment end date
2019-03-06, 1397/12/15
Trial completion date
2019-03-06, 1397/12/15
Scientific title
Effect of specific diet in treatment of patients with persistent microscopic hematuria
Public title
Specific diet and hematuria
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Isolated microscopic hematuria without a known cause Age 6 months to 16 years
Exclusion criteria:
Possibility of upper urinary tract diseases (including glomerular diseases such as IgA Nephropathy, Thoracic Disease, Alport Syndrome, Post-infection Glomerulonephritis, Membrane Nephropathy) Patients infected with uremic hemolytic syndrome and sickle cell disease Multiple Systemic Diseases (such as Lupus, Henoch Schwein Line Purpura, Wegener, Nodosa Polyurethritis, Goodpasture) Interstitial diseases (such as pyelonephritis, interstitial nephritis, papillary necrosis and acute tubular necrosis and vascular diseases and anatomical causes such as hydronephrosis, cystic kidney and tumor diseases and trauma) Inflammations of the lower urinary tract such as (cystitis, urethritis, stones), coagulopathy, tumor, infection, and fabricated hematuria factitious hematuria
Age
From 2 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 122
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of faculty of medicine
Street address
Shariati Avnue
City
Tehran
Province
Tehran
Postal code
15468-15514
Approval date
2018-12-24, 1397/10/03
Ethics committee reference number
IR.SBMU.MSP.REC.1398.046

Health conditions studied

1

Description of health condition studied
Bloody urine
ICD-10 code
N02
ICD-10 code description
Recurrent and persistent hematuria

Primary outcomes

1

Description
Number of urine red blood cells
Timepoint
At first (before intervention) and 1month after diet
Method of measurement
Urine analysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1 group: Intervention as non-allergen food (hypoallergenic Diet) on Patients with asymptomatic microscopic hematuria without any kind of treatment. (Special hypoallergenic diet: omit Salty snack, Chocolates, Fast foods, Industrial beverages and Spicy food from child's diet for 4 weeks).
Category
Treatment - Other

2

Description
Control group: Intervention 2 group (control group): Patients with asymptomatic microscopic hematuria without any kind of diet or treatment, they just should be followed. (Usually pediatric patients with asymptomatic microscopic hematuria do not receive any medication or diet and just are followed).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mofid children's hospital- pediatric nephrology clinic
Full name of responsible person
Masoumeh Mohkam
Street address
Mofid children's hospital, Shariati Ave. Tehran- Iran
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7033
Fax
Email
mohkam@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Mohkam
Street address
Shahid Beheshti University of Medical Sciences- Velenjak - Tehran
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 7033
Email
mohkam@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Mohkam
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Chioldren's hospital- Shariati Ave, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 9658
Email
mohkam@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Mohkam
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Chioldren's hospital- Shariati Ave, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 9658
Email
mohkam@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Mohkam
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Mofid Chioldren's hospital- Shariati Ave, Tehran , Iran
City
Tehran
Province
Tehran
Postal code
15468-15514
Phone
+98 21 2222 9658
Email
mohkam@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This is a localized study
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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