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General information
empty
In section Sharing plan: The item "Undecided" was updated to "Yes - there is a plan to make this available"
In section Sharing plan: The item "Undecided" was updated to "Yes - there is a plan to make this available"
empty
در قسمت برنامه به اشتراک گزاری طرح:
در مرحله قبل در ارتباط با به اشتراک گذاری آیتم "بدون پیش بینی" به "بله داده های طرح در دسترس قرار خواهد گرفت" به روز رسانی شد.
در قسمت برنامه به اشتراک گزاری طرح: در مرحله قبل در ارتباط با به اشتراک گذاری آیتم "بدون پیش بینی" به "بله داده های طرح در دسترس قرار خواهد گرفت" به روز رسانی شد.
Sharing plan
undecided
yes
undecidedyes
There is no further information
empty
There is no further information
اطلاعات بیشتری وجود ندارد
empty
اطلاعات بیشتری وجود ندارد
manuscripts will be published based on this data
the primary outcome measures
manuscripts will be published based on this datathe primary outcome measures
مقالات قابل انتشار از نتایج داده ها
اطلاعات مربوط به پیامد اصلی
مقالات قابل انتشار از نتایج داده هااطلاعات مربوط به پیامد اصلی
End of study
six months after publishing paper/ until 2 years after the end of the study
Endsix months after publishing paper/ until 2 years after the end of the study
انتها مطالعه
شش ماه بعد از انتشار مقاله/ تا 2 سال بعد از اتمام پروژه
انتها مطالعهشش ماه بعد از انتشار مقاله/ تا 2 سال بعد از اتمام پروژه
For all researchers and clinicians
Based on the Iran Ministry of a health condition related to clinical trials
For all researchers and cliniciansBased on the Iran Ministry of a health condition related to clinical trials
برای همه محققین و متخصصین بالینی
برای همه محققین که در راستای اهداف مطالعه تحقیق میکنند.
برای همه محققین و متخصصین بالینیکه در راستای اهداف مطالعه تحقیق میکنند.
بر اساس معیارهای وزارت بهداشت در ارتباط با مطالعات کلینیکال ترایال
با هماهنگی و تایید مجری طرح و بر اساس معیارهای وزارت بهداشت در ارتباط با مطالعات کلینیکال ترایال
با هماهنگی و تایید مجری طرح و بر اساس معیارهای وزارت بهداشت در ارتباط با مطالعات کلینیکال ترایال
Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran
the email address of the principal investigator
Deputythe email address of Research and Technology, Tehran University of Medical Sciences, Tehran, Iranthe principal investigator
معاونت پژوهشی دانشگاه علوم پزشکی تهران
آدرس ایمیل مجری
معاونت پژوهشی دانشگاه علوم پزشکی تهرانآدرس ایمیل مجری
There is no further information
The request will be reviewed by the project executors and then Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran.
There is no further informationThe request will be reviewed by the project executors and then Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran.
اطلاعات بیشتری وجود ندارد.
درخواست ابتدا توسط مجریان پروژه بررسی خواهد شد و سپس در کمیته پژوهشی دانشگاه علوم پزشکی تهران مطرح خواهد شد
اطلاعات بیشتری وجود ندارد.درخواست ابتدا توسط مجریان پروژه بررسی خواهد شد و سپس در کمیته پژوهشی دانشگاه علوم پزشکی تهران مطرح خواهد شد
Protocol summary
Study aim
to determine the effect of oral 25(OH)D on serum levels of 25(OH)D and association to the primary and secondary outcomes of COVID-19 infection in affected patients.
Design
double blind, randomised controlled trial
Settings and conduct
The project will perform in Sina hospital as a COVID-19 center.
Subjects including patients with positive COVID-19
Participants, physicians, data collectors, and project executives are blind to the type of medication (medication and placebo).
The coordinator will determine this with a computer-generated randomization program.
Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. COVID-19 positive in the patient group
Exclusion criteria:
1.Ongoing treatment with vitamin D metabolites or analogs or consuming medication affecting bone metabolism
2.History of chronic disorders such as hepatic or renal failure, malabsorption syndrome
3.Inability to give informed consent
Intervention groups
Subjects in the intervention group will receive 1000 IUs of 25(OH)D daily for 8 wks and controls will receive placebo daily for 8 wks.
Main outcome variables
Duration of infection
Dyspnea experience
duration of hospitalization
Admitted to ICU: duration
Incubation period
Lymphopenia
Mortality during 60 days of study
General information
Reason for update
In section Sharing plan: The item "Undecided" was updated to "Yes - there is a plan to make this available"
Acronym
IRCT registration information
IRCT registration number:IRCT20200401046909N1
Registration date:2020-04-09, 1399/01/21
Registration timing:prospective
Last update:2020-06-01, 1399/03/12
Update count:2
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
Zhila Maghbooli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 6142
Email address
zhilayas@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-15, 1399/01/27
Expected recruitment end date
2020-10-30, 1399/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of oral 25-hydroxyvitamin D3 on COVID-19 treatment in adults: A Randomized, Controlled Double-Blind Clinical Trial.
Public title
Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2019-nCov (SARA-Cov-2) nucleic acid positive will be detected by PCR in affected patients
older than 17 years old and younger than 76 years old.
No medications or disorders that would affect vitamin D metabolism
Women must be not pregnant at baseline and during study
Ability and willingness to give informed consent and comply with protocol requirements
Exclusion criteria:
Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogues
Pregnant or lactating women;
Severe underlying diseases, such as advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium >9.8 mg/dl)
Chronic hepatic or renal failure or patients with reduced kidney function, cancers, and malabsorption syndrome, a granulomatous disorders such as Sarcoidosis or Tuberculosis
Supplementation with over the counter formulations of vitamin D2 or vitamin D3
Use of tanning bed or artificial UV exposure within the last two weeks.
Consuming medication affecting bone metabolism (anti-convulsants, anti-tuberculosis medication, cimetidine, theophylline, and cholestyramine), as well as
those who are following special diets such as vegetarian diet or consuming fortified products regularly.
Subjects with a history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogues.
Inability to give informed consent
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, 260 patients with positive COVID-19 will be recruited. Patients will be randomly allocated to the drug group (N=130) and placebo group (N=130).
The randomization method is "restricted randomization". It will be determined by a "Random Allocation Software".
Subjects in the drug group will receive 1000 IUs of 25(OH)D daily for 8 wks and subjects in the placebo group will receive placebo daily for 8 wks.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, physicians, data collectors, and project executives are blind to the type of medication (medication and placebo).
The drug and placebo are coded by someone else. This person has no role in treatment, data collection and data analysis. The codes are randomly selected for each participant. Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the participants.
medication: containing 25OHD soft gelatin capsular
placebo: containing white to off white color suspension oil
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research deputy of Tehran University of Medical Sciences, Qods building, Qods St. Cross, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.TUMS.VCR.REC.1399.061
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
SARS-associated coronavirus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
infection duration
Timepoint
during study
Method of measurement
WHO criteria
Secondary outcomes
1
Description
severity of disease (mild, moderate, sever)
Timepoint
during study
Method of measurement
Dyspnea, Palsoximethry result, CBC diff, Blood gas parameters, and acid-base, CT scan result
2
Description
serum levels of Vitamin D
Timepoint
before intervention, end of 4th and end of 8th intervention
Method of measurement
HPLC method
Intervention groups
1
Description
Intervention group: containing 25OHD soft gelatin capsular 1000 IU , Producer: Dishmen. the case group will receive 1000 IUs of 25(OH)D daily for 8 wks. The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the 25(OH)D. The bottles will be returned to be checked at each visit.
Category
Prevention
2
Description
Placebo: containing white to off white color suspension oil. Producer: Dishmen Company. The control group will receive placebo daily for 8 wks..The subjects will receive a bottle containing 30 capsules in first and second visits that will contain the placebo. The bottles will be returned to be checked at each visit.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammadali Sahraian
Street address
Emamkhomeini St., Hasanabad Sq.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Email
sahraian1350@yahoo.com
2
Recruitment center
Name of recruitment center
Ziaian Hospital
Full name of responsible person
Sied Reza Jamali Moghadam
Street address
24 metri Abouzar St.
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 6670 6142
Email
ms.genelab@gmail.com
3
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Neda Alijani
Street address
North Karegar St.
City
Tehran
Province
Tehran
Postal code
1411713118
Phone
+98 21 6670 6142
Email
dna1461@yahoo.com
4
Recruitment center
Name of recruitment center
Pakdasht Hospital
Full name of responsible person
Zhila Maghbooli
Street address
Pakdasht Varamin
City
Tehran
Province
Tehran
Postal code
1411713118
Phone
+98 21 6670 6142
Email
zhilayas@gmail.com
5
Recruitment center
Name of recruitment center
Emamkhomeini Hospital
Full name of responsible person
Zhila Maghbooli
Street address
Cross Keshavarz Bulv. and Dr Gharib St.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6670 6142
Email
zhilayas@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraian, Research Deputy
Street address
Qods St, Keshavarz Bulv.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3691
Email
tums_edu@tumc.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
Zhila Maghbooli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Genetics
Street address
Emamkhomeini St., Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Fax
Email
zhilayas@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boston University of Medical Sciences
Full name of responsible person
Arash Shirvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
02118
City
Boston
Province
MA
Postal code
02118
Phone
0016178701376
Email
arash_hs@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zhila Maghbooli
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Sina hospital, Emamkhomeini St., Hasanabad Sq.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6670 6142
Email
zhilayas@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
the primary outcome measures
When the data will become available and for how long
six months after publishing paper/ until 2 years after the end of the study
To whom data/document is available
Based on the Iran Ministry of a health condition related to clinical trials
Under which criteria data/document could be used
Based on Iran Ministry of Health condition related to clinical trials
From where data/document is obtainable
the email address of the principal investigator
What processes are involved for a request to access data/document
The request will be reviewed by the project executors and then Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran.