evaluation of effect of vitamin D supplement on urinary calcium and stone forming rate of patients with urilithiasis and vitamin D deficiency
Design
patients aged 20 to 65 years who suffered vitamin D deficiency (serum vitamin D level < 30 ng/ml) and also history of nephrolithiasis with at least two episodes of stone recurrence or increase in stone size within the last five years who have not exclusion criteria will be included. serum levels of calcium, creatinine, uric acid, 25OHD, and parathormone and 24-hour urine concentration of creatinine, citrate, oxalate, sodium, uric acid, and calcium at the time of enrollment and three months after starting the vitamin D consumption will be measured. then this parameters with information like age,sex,BMI and hypertension if exists will be analyzed with SPSS software.
Settings and conduct
out patients who referred to nephrology department of Shariati hospital or private clinic of the researcher
Participants/Inclusion and exclusion criteria
urinary stone former patients who have vitamin D deficiency and sign the constant form and have not below criteria:
pregnant patients, hypercalcemia (baseline calcium level of ≥10.4 mg/dl), medications that affect calcium and bone metabolism (such as calcium) or calcium excretion (such as steroidal or hormonal drugs), previous history of primary hyperparathyroidism or other systemic diseases (cancer, alcoholic liver disease and osteoporosis) patients who had invasive diagnostic or therapeutic interventions on renal stones within the last month prior to enrollment known case of uric acid ,cysteine or steruvite urinary stone
Intervention groups
All 30 patients with inclusion criteria who have not exclusion criteria receive vitamin D pearl and after and before intervention lab test will be compare
Main outcome variables
changes rate of 24 hour urine calcium and amount of new stone formation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180108038262N2
Registration date:2018-08-10, 1397/05/19
Registration timing:retrospective
Last update:2018-08-10, 1397/05/19
Update count:0
Registration date
2018-08-10, 1397/05/19
Registrant information
Name
Zahra Shafii
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2315 2013
Email address
shafii_zahra@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-12-29, 1394/10/08
Actual recruitment start date
2014-01-01, 1392/10/11
Actual recruitment end date
2015-12-20, 1394/09/29
Trial completion date
empty
Scientific title
evaluation of effect of Vitamin D supplementation on hypercalciuria in vitamin D deficient recurrent stone former patients
Public title
The use of vitamin D supplementation and risk of hypercalciuria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
urinary stone former
vitamin D defficiency
sign the constant form
Exclusion criteria:
pregnant patients
hypercalcemia (baseline calcium level of ≥10.4 mg/dl)
medications that affect calcium and bone metabolism (such as calcium) or calcium excretion (such as steroidal or hormonal drugs),
previous history of primary hyperparathyroidism or other systemic diseases (cancer, alcoholic liver disease and osteoporosis)
patients who had invasive diagnostic or therapeutic interventions on renal stones within the last month prior to enrollment
known case of uric acid ,cysteine or steruvite urinary stone
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Science Ethics Committee
Street address
Ghods Street,Keshavarz Blvd, Central Organization of University of Medical Science, 6th floor
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
91-02-146-18306
Health conditions studied
1
Description of health condition studied
urolithiasis
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter
2
Description of health condition studied
vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified
Primary outcomes
1
Description
amount of increase in urinary calcium
Timepoint
before and after 3 month of vitamin D prescription
Method of measurement
measurement of calcium in 24 hour urine
2
Description
urinary stone formation
Timepoint
3 month after treatment
Method of measurement
ultrasound examination
Secondary outcomes
1
Description
serum parathyroid change
Timepoint
before and 3 month after vitamin D prescription
Method of measurement
laboratory measurment
Intervention groups
1
Description
Intervention group: administration of vitamin D pearl 50000 unit weekly for 2 month and then every 2 weak until third month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hoapital
Full name of responsible person
Mohammadreza Ganji
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mrezaganji@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeeyan
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ganji
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mrezaganji@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ganji
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mrezaganji@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ganji
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati Hospital, Jalal Ale Ahmad Ave, North Karegar St, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
mrezaganji@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available