Comparing the effect of oral stripe and perl vitamin D in patients with vitamin D deficiency
Design
A clinical trial with a control group, with parallel groups, single blind, randomized
Settings and conduct
This study is a randomized, single blinded clinical trial (only analyst will not be aware of patients' grouping) on patients suffering from deficiency and inadequate vitamin D in a Golestan Hospital in 2012 for 2 months.Blindness inThis study will be conducted as a single blind so that the statistical analyzer does not know which patients are present in the group.
Participants/Inclusion and exclusion criteria
The criteria for entering the patients are:
1. Reduce the level of vitamin D3 (25OH Vitamin D) from normal range (<32ng / ml).2. Age of patients older than 7 years;Exit criteria for the study include:1. Drinking alcohol or drugs.2. The patient will not be able to use Perl vitamin D3 or oral stripe.3. Patients with hypercalciuria, hyperparathyroidism, hypothyroidism, patients taking anti-seizure drugs, anti-tuberculosis, typhylline and vitamin D supplements, and those with malabsorption syndrome, celiac disease, and liver and kidney failure. They will be out.
Intervention groups
In this study, 50 patients with reduced vitamin D3 will be selected from normal range (32> ng / ml). For all patients, serum vitamin D3 levels will be measured at the beginning of the study and at the end of the study (after 8 weeks). In this study, patients will be randomized into two groups. Which will be given to a perl group of vitamins D3 of 50,000 units once a week for 8 weeks (control group) and to another group of oral stretch form 2000 units per day.
Main outcome variables
vitamin D3 serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039235N1
Registration date:2018-07-11, 1397/04/20
Registration timing:retrospective
Last update:2018-07-11, 1397/04/20
Update count:0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Aryan Yousefi Fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 9992
Email address
yousefifard.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-05-31, 1397/03/10
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2018-02-14, 1396/11/25
Trial completion date
empty
Scientific title
comparing the effect of oral stripe and vitamin D3 pearl, in patiens with vitamin D deficiency in single blind clinical trial
Public title
Evaluating the effectiveness of oral stripe and perl vitamin D in vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Decreased vitamin D levels from normal range (32 ng / ml)
Age of patients older than 7 years
Exclusion criteria:
Company dissatisfaction with the study
Drinking alcohol or drugs
The patient will not be able to use Perl vitamin D3 or oral strip
Patients with hypercalciuria, hyperparathyroidism, hypothyroidism, patients taking anti-seizure drugs, anti-tuberculosis, typhylline and vitamin D supplements, and those with malabsorption syndrome, celiac disease, and liver and kidney failure
Age
From 7 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Replacement randomization method is used for randomization so that completely randomized individuals are divided into two groups. Curing: This study will be conducted as a single blind so that the statistical analyzer is from which group of patients were present.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study will be done side by side so that the statistical analyzer does not know which patients are present in the group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Johndishapur University of Medical Sciences
Street address
Medical Sciences Blvd، Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.AJUMS.REC.1397.112
Health conditions studied
1
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
Measuring serum vitamin D levels
Timepoint
8 Week
Method of measurement
Serum test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Pearl recipients of vitamin D, For 30 patients, 50,000 units of vitamin D (zhravi company) once a week were administered orally for 8 weeks (control group) .
Category
Treatment - Drugs
2
Description
Intervention group: Strip recipients of vitamin D, and for 30 others oral strip 2000 units of vitamin D (ramopharmin company) administered daily for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Aryan Yousefi Fard
Street address
Johondishapour University of Medical Sciences ,Medical Sciences Blvdahvaz, khozestan provice
City
Ahvaz
Province
Khouzestan
Postal code
68138_54617
Phone
+98 61 3443 9992
Email
yousefifard.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Ganji
Street address
Daneshjou Blvd، Johndishapur University of Medical Sciences,
City
Ahvaz
Province
Khouzestan
Postal code
68138_54617
Phone
+98 66 3330 7277
Email
Rg.pharm777@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Aryan Yousefi Fard
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshjou Blvd,Johndishapur University of Medical Sciences,
City
Ahvaz
Province
Khouzestan
Postal code
68138-54617
Phone
+98 61 3443 9992
Email
yousefifard.a@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Aryan Yousefi Fard
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshjou Blvd، Johndishapur University of Medical Sciences,
City
Ahvaz
Province
Khouzestan
Postal code
68138-54617
Phone
+98 916 398 2281
Email
yousefifard.a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Aryan Yousefi Fard
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Medical Sciences Blvd, Ahvaz،Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
68138-54617
Phone
+98 61 3443 9992
Email
yousefifard.a@ajums.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
No more information
Study Protocol
No - There is not 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