Comparison of Oral & Intramuscular injection form of Vitamin D prescription on the Serum 25-Hydroxy-vitamin D level in patients with vitamin D deficiency
Comparison of Oral & Intramuscular injection form of Vitamin D prescription on the Serum 25-Hydroxy-vitamin D level in patients with vitamin D deficiency
Design
Two arm parallel group clinical trial, double blinded, non-randomized, phase 3 on 150 patients in each group
Settings and conduct
This study is done on patients referred to endocrinology & rheumatology clinics of Ayatolah Rouhani`s hospital.
Only the clinician knows the drug prescribed in every group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Everybody older than 18 years referred to endocrinology & rheumatology clinic that have serum 25(OH)D3 level lower than 20 ng/mL
Exclusion criteria:
1- patient dissatisfaction
2- Known gastrointestinal disease effective on vitamin D absorption
3- Low serum albumin level
4- Chronic Renal Failure
5- Hepatic failure
6- Taking medication effective on vitamin D & calcium metabolism
7- Pregnancy
8- Malignancy
9- Untreated thyroid disorder
10- Primary hyperparathyroidism
Intervention groups
In one group, vitamin D in the form of 50000 U orally pearl is prescribed weekly, up to 8 weeks, and in another group an single dose of intramuscular injection of 300000 U ampule is prescribed.
Main outcome variables
Determining of the most appropriate & the most reliable method of replacement of vitamin D deficiency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191030045277N1
Registration date:2020-06-23, 1399/04/03
Registration timing:registered_while_recruiting
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
mohammadali bayani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8284
Email address
bayanima49@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-29, 1398/10/08
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Oral & Intramuscular injection form of Vitamin D prescription on the Serum 25-Hydroxy-vitamin D level in patients with vitamin D deficiency
Public title
Comparison of Oral & Intramuscular injection form of Vitamin D in patients with vitamin D deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Every body older than 18 years
Serum 25(OH)D3 level lower than 20 ng/mL
Exclusion criteria:
Patient dissatisfaction
Known gastrointestinal disease effective on vitamin D absorption
Low serum albumin level
Chronic Renal Failure
Hepatic failure
Taking medication effective on vitamin D & calcium metabolism
Pregnancy
Malignancy
Untreated thyroid disorder
Primary hyperparathyroidism
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Based on the ticket number being even or odd, the patient will placed on group A or B, and one of the oral or injection form of vitamin D will prescribed by clinician. The patient doesn`t know the way of treatment of others. The researcher, the outcome evaluator, and data analyzer know the group A & B results only, not the form of drug that was prescibed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj afruz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2019-12-29, 1398/10/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.267
Health conditions studied
1
Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55
ICD-10 code description
Vitamin D deficiency
Primary outcomes
1
Description
Serum level of vitamin D
Timepoint
Measurement of serum level of vitamin D at the beginning of study & the end of eighth week
Method of measurement
Based on measurement of serum level of vitamin D in laboratory
Secondary outcomes
1
Description
Serum level of vitamin D
Timepoint
Measurement of serum level of vitamin D at the beginning of study & the end of eighth week
Method of measurement
Based on measurement of serum level of vitamin D in laboratory
Intervention groups
1
Description
Intervention group 1: For patients in this group, the pearl of vitamin D (D-vitin, the product of Zahravi`s company) 50000 U weekly until eight weeks is prescribed, and serum level of vitamin D is measured at the end of eighth week again.
Category
Treatment - Drugs
2
Description
Intervention group 2: For patients in this group, injection form of vitamin D (the product of Osvah`s company) 300000 U single dose is prescribed, and serum level of vitamin D is measured at the end of eighth week after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Mohammadali Bayani
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
info@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
Info@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadali Bayani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinologist and Metabolism Specialist
Street address
Ganj Afrooz Road, Babol Rohani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3223 8309
Email
bayanima49@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the data related to the main topic is displayed.
When the data will become available and for how long
Start of access period 6 months after printing result.
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
No special conditions
From where data/document is obtainable
Babol University of Medical Sciences, Ruhani`s hospital, Dr. Mohammad Ali Bayani
What processes are involved for a request to access data/document
Refer to Ruhani`s hospital and talk to Dr. Mohammad Ali Bayani and access to information