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General information
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1. the upper limit for calcium is 10.6 mg/dl
2. COVID-19 diagnosis criteria in Iran COVID centers are based on the following criteria:
patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
1. the upper limit for calcium is 10.6 mg/dl 2. COVID-19 diagnosis criteria in Iran COVID centers are based on the following criteria: patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
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1. سطح نرمال بالایی کلسیم 10.6 میلیگرم بر دسی لیتر.
2. تشخیص کووید در مراکز آموزشی ایران بر اساس کرایتریا زیر می باشد:
بیماران بالاتر از 18 سال با علائم عفونت حاد دستگاه تنفسی (مانند تب ، سرفه ، تنگی نفس) بودن علت شناخته شده دیگر همراه با توموگرافی کامپیوتری قفسه سینه (CT) یا تشخیص با واکنش زنجیره ای پلیمراز (PCR)
1. سطح نرمال بالایی کلسیم 10.6 میلیگرم بر دسی لیتر. 2. تشخیص کووید در مراکز آموزشی ایران بر اساس کرایتریا زیر می باشد: بیماران بالاتر از 18 سال با علائم عفونت حاد دستگاه تنفسی (مانند تب ، سرفه ، تنگی نفس) بودن علت شناخته شده دیگر همراه با توموگرافی کامپیوتری قفسه سینه (CT) یا تشخیص با واکنش زنجیره ای پلیمراز (PCR)
Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs
Pregnant or lactating women
Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium levels more than 9.8 mg/dl
History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or 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)
Following special diets such as vegetarian diet or consuming fortified products regularly
A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs
Inability to give informed consent
Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs
Pregnant or lactating women
Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium levels more than 10.6 mg/dl
History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or 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)
Following special diets such as vegetarian diet or consuming fortified products regularly
A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs
Inability to give informed consent
Ongoing treatment with pharmacologic doses of vitamin D, vitamin D metabolites or analogs Pregnant or lactating women Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc. History of elevated serum calcium levels more than 9.810.6 mg/dl History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or 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) Following special diets such as vegetarian diet or consuming fortified products regularly A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs Inability to give informed consent
مصرف ویتامین د، متابولیت ها و یا انالوگ ویتامین د
بارداری و یا شیردهی
مبتلا به بیماریهای مزمن شدید همچون سرطان، بیماریهای ریوی مرحله نهایی، ..
سابقه کلسیم بالاتر از 9.8 mg/dl
سابقه نارسایی کبدی، کلیوی، یا بیماران با سابقه کاهش فعالیت کلیوی، سابقه کانسر، سندروم سوء جذب، سابقه بیماریهای گرانولوماتوز مثل سل و سارکوئیدوز
مصرف مکمل های حاوی ویتامین د3 و یا د 2
استفاده از سولاریوم برای برنزه شدن طی دو هفته قبل از ورود به مطالعه
مصرف داروهایی که بر متابولیسم استخوانی اثر دارد همچون داروهای ضد تشنج، داروهای ضد سل، سیمتدین، تئوفیلین، کلسترامین، ..
رعایت رژیم غذایی خاص همچون گیاهخواری و یا مصرف محصولات غنی شده به طور منظم
سابقه واکنش نامطلوب به مصرف خوراکی ویتامین د: متابولیت ها و یا انالوگ ویتامین د
عدم توانایی در رضایت آگاهانه
مصرف ویتامین د، متابولیت ها و یا انالوگ ویتامین د
بارداری و یا شیردهی
مبتلا به بیماریهای مزمن شدید همچون سرطان، بیماریهای ریوی مرحله نهایی، ..
سابقه کلسیم بالاتر از 10.6 mg/dl
سابقه نارسایی کبدی، کلیوی، یا بیماران با سابقه کاهش فعالیت کلیوی، سابقه کانسر، سندروم سوء جذب، سابقه بیماریهای گرانولوماتوز مثل سل و سارکوئیدوز
مصرف مکمل های حاوی ویتامین د3 و یا د 2
استفاده از سولاریوم برای برنزه شدن طی دو هفته قبل از ورود به مطالعه
مصرف داروهایی که بر متابولیسم استخوانی اثر دارد همچون داروهای ضد تشنج، داروهای ضد سل، سیمتدین، تئوفیلین، کلسترامین، ..
رعایت رژیم غذایی خاص همچون گیاهخواری و یا مصرف محصولات غنی شده به طور منظم
سابقه واکنش نامطلوب به مصرف خوراکی ویتامین د: متابولیت ها و یا انالوگ ویتامین د
عدم توانایی در رضایت آگاهانه
مصرف ویتامین د، متابولیت ها و یا انالوگ ویتامین د بارداری و یا شیردهی مبتلا به بیماریهای مزمن شدید همچون سرطان، بیماریهای ریوی مرحله نهایی، .. سابقه کلسیم بالاتر از 9.810.6 mg/dl سابقه نارسایی کبدی، کلیوی، یا بیماران با سابقه کاهش فعالیت کلیوی، سابقه کانسر، سندروم سوء جذب، سابقه بیماریهای گرانولوماتوز مثل سل و سارکوئیدوز مصرف مکمل های حاوی ویتامین د3 و یا د 2 استفاده از سولاریوم برای برنزه شدن طی دو هفته قبل از ورود به مطالعه مصرف داروهایی که بر متابولیسم استخوانی اثر دارد همچون داروهای ضد تشنج، داروهای ضد سل، سیمتدین، تئوفیلین، کلسترامین، .. رعایت رژیم غذایی خاص همچون گیاهخواری و یا مصرف محصولات غنی شده به طور منظم سابقه واکنش نامطلوب به مصرف خوراکی ویتامین د: متابولیت ها و یا انالوگ ویتامین د عدم توانایی در رضایت آگاهانه
Primary outcomes
#1
COVID-19 positive by PCR
patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
COVIDpatients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 positive by or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
تست مثبت COVID-19 با PCR
بیماران بالاتر از 18 سال با علائم عفونت حاد دستگاه تنفسی (مانند تب ، سرفه ، تنگی نفس) بودن علت شناخته شده دیگر همراه با توموگرافی کامپیوتری قفسه سینه (CT) یا تشخیص با واکنش زنجیره ای پلیمراز (PCR)
تست مثبت COVID-19بیماران بالاتر از 18 سال با علائم عفونت حاد دستگاه تنفسی (مانند تب ، سرفه ، تنگی نفس) بودن علت شناخته شده دیگر همراه با توموگرافی کامپیوتری قفسه سینه (CT) یا تشخیص با واکنش زنجیره ای پلیمراز (PCR)
Recruitment centers
#1
Name of recruitment center - English: Sina hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Mohammadali Sahraian
Full name of responsible person - Persian: محمد علی صحراییان
Street address - English: Emamkhomeini St., Hasanabad Sq.
Street address - Persian: خیابان امام خمینی، میدان حسن آباد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1136746911
Phone: +98 21 6670 6142
Fax:
Email: sahraian1350@yahoo.com
Web page address:
Name of recruitment center - English: Emam khomeini
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Zhila Maghbooli
Full name of responsible person - Persian: ژیلا مقبولی
Street address - English: Cross Keshavarz Bulv. and Dr Gharib St.
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1419733141
Phone: +98 21 6670 6142
Fax:
Email: zhilayas@gmail.com
Web page address:
Name of recruitment center - English: Sina hospitalEmam khomeini Name of recruitment center - Persian: بیمارستان سیناامام خمینی Full name of responsible person - English: Mohammadali SahraianZhila Maghbooli Full name of responsible person - Persian: محمد علی صحراییانژیلا مقبولی Street address - English: EmamkhomeiniCross Keshavarz Bulv. and Dr Gharib St., Hasanabad Sq. Street address - Persian: انتهای بلوار کشاورز، خیابان امام خمینی، میدان حسن آباددکتر قریب City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 11367469111419733141 Phone: +98 21 6670 6142 Fax: Email: sahraian1350zhilayas@yahoo.comgmail.com Web page address:
#2
Name of recruitment center - English: Emamkhomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Zhila Maghbooli
Full name of responsible person - Persian: ژیلا مقبولی
Street address - English: Cross Keshavarz Bulv. and Dr Gharib St.
Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریب
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۱۹۷۳۳۱۴۱
Phone: +98 21 6670 6142
Fax:
Email: zhilayas@gmail.com
Web page address:
Name of recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Neda Alijani
Full name of responsible person - Persian: ندا علیجانی
Street address - English: North Karegar St.
Street address - Persian: کارگر شمالی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713118
Phone: +98 21 6670 6142
Fax: +98 21 6670 6142
Email: dna1461@yahoo.com
Web page address:
Name of recruitment center - English: EmamkhomeiniShariati Hospital Name of recruitment center - Persian: بیمارستان امام خمینیشریعتی Full name of responsible person - English: Zhila MaghbooliNeda Alijani Full name of responsible person - Persian: ژیلا مقبولیندا علیجانی Street address - English: Cross Keshavarz Bulv. and Dr GharibNorth Karegar St. Street address - Persian: انتهای بلوار کشاورز، خیابان دکتر قریبکارگر شمالی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۱۹۷۳۳۱۴۱1411713118 Phone: +98 21 6670 6142 Fax: +98 21 6670 6142 Email: zhilayasdna1461@gmail.comyahoo.com Web page address:
#3
Name of recruitment center - English: PAkdasht Hospital
Name of recruitment center - Persian: بیمارستان پاکدشت
Full name of responsible person - English: Zhila Maghbooli
Full name of responsible person - Persian: ژیلا مقبولی
Street address - English: Varamin Pakdasht
Street address - Persian: پاکدشت ورامین
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713118
Phone: +98 21 6670 6142
Fax:
Email: zhilayas@gmail.com
Web page address:
Name of recruitment center - English: PAkdasht Hospital Name of recruitment center - Persian: بیمارستان پاکدشت Full name of responsible person - English: Zhila Maghbooli Full name of responsible person - Persian: ژیلا مقبولی Street address - English: Varamin Pakdasht Street address - Persian: پاکدشت ورامین City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713118 Phone: +98 21 6670 6142 Fax: Email: zhilayas@gmail.com Web page address:
#4
Name of recruitment center - English: Ziaian Hospital
Name of recruitment center - Persian: بیمارستان ضیائیان
Full name of responsible person - English: Sied Reza Jamali Moghadam
Full name of responsible person - Persian: سعید رضا جمالی مقدم
Street address - English: 24 metri Abouzar St.
Street address - Persian: خیابان 24 متری ابوذر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1366736511
Phone: +98 21 6670 6142
Fax:
Email: ms.genelab@gmail.com
Web page address:
Name of recruitment center - English: Ziaian Hospital Name of recruitment center - Persian: بیمارستان ضیائیان Full name of responsible person - English: Sied Reza Jamali Moghadam Full name of responsible person - Persian: سعید رضا جمالی مقدم Street address - English: 24 metri Abouzar St. Street address - Persian: خیابان 24 متری ابوذر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1366736511 Phone: +98 21 6670 6142 Fax: Email: ms.genelab@gmail.com Web page address:
Protocol summary
Study aim
1. To determine the effect of oral supplementation by 25(OH)D on serum levels of 25(OH)D and relate this to decrease the incidence of Coronavirus infection in health providers and family members of COVID-19 patients
2. To determine the effect of oral supplementation by 25(OH)D on serum levels of 25(OH)D and relate this to the primary and secondary outcomes of Coronavirus infection in newly affected patients.
Design
A double-blind, randomized controlled trial
Settings and conduct
The project will perform in as COVID-19 centers affiliated to the Tehran University of medical sciences.
Subjects include health providers and the patients' relatives with negative COVID-19.
Subjects will be allocated to the intervention or placebo groups. The coordinator will determine this with a computer-generated randomization program. The coordinator does not involve the treatment process and data gathering and data analysis.
Participants, physicians, data collectors, and project executives are blind to the type of medication (intervention and placebo). Each patient has a specific code. Based on the drug coding, the physician or researcher will provide the drug to the subjects.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not affected by COVID-19 (based on WHO criteria)
Exclusion criteria:
Ongoing treatment with vitamin D metabolites or analogs or consuming medication affecting bone metabolism
History of chronic disorders
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
1. The number of new cases with COVID-19
2.Duration of infection
3.Dyspnea experience
4.Duration of hospitalization
5.Admitted to ICU: duration
6.Incubation period
7.Lymphopenia
8.Mortality during 60 days of study
General information
Reason for update
1. the upper limit for calcium is 10.6 mg/dl
2. COVID-19 diagnosis criteria in Iran COVID centers are based on the following criteria:
patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
Acronym
IRCT registration information
IRCT registration number:IRCT20200401046909N2
Registration date:2020-04-11, 1399/01/23
Registration timing:prospective
Last update:2020-05-10, 1399/02/21
Update count:2
Registration date
2020-04-11, 1399/01/23
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
2020-04-14, 1399/01/26
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
Investigating preventive effects of oral 25-hydroxyvitamin D3 on COVID-19 in adults: A Randomized, Controlled Double-Blind Clinical Trial.
Public title
Evaluation of the efficacy of oral 25-hydroxyvitamin D3 on COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Non-infected with COVID-19 (based on WHO criteria)
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 analogs
Pregnant or lactating women
Severe underlying diseases, such as an advanced malignant tumor, end-stage lung disease, etc.
History of elevated serum calcium levels more than 10.6 mg/dl
History of chronic hepatic, renal failure or patients with reduced kidney function, cancers, malabsorption syndrome, or 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)
Following special diets such as vegetarian diet or consuming fortified products regularly
A history of an adverse reaction to orally administered vitamin D, vitamin D metabolites or analogs
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:
540
Randomization (investigator's opinion)
Randomized
Randomization description
in this study, the random allocation for intervention and placebo groups is based on a "Random Allocation Software".
A simple randomized list will be produced by the software for a sample size of 540 subjects into two groups of the intervention and placebo with equal sample size and numeric sequential unique.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is a double-blind clinical trial. 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
Affected by COVID-19
Timepoint
Sign of COVID-19 during study
Method of measurement
patients over 18 years of age with acute respiratory tract infection symptoms (e.g. fever, cough, dyspnea) with no other etiology that fully explains the clinical presentation accompanied by chest computed tomography (CT) scan findings compatible with Covid-19 or definite diagnosis of Covid-19 with real-time polymerase chain reaction (PCR)
Secondary outcomes
1
Description
Infection duration
Timepoint
During study
Method of measurement
WHO criteria
2
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
3
Description
Serum levels of Vitamin D
Timepoint
Before intervention, end of 4th and end of 8th intervention
Method of measurement
HPLC
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
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini
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
Fax
Email
zhilayas@gmail.com
2
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
Fax
+98 21 6670 6142
Email
dna1461@yahoo.com
3
Recruitment center
Name of recruitment center
PAkdasht Hospital
Full name of responsible person
Zhila Maghbooli
Street address
Varamin Pakdasht
City
Tehran
Province
Tehran
Postal code
1411713118
Phone
+98 21 6670 6142
Email
zhilayas@gmail.com
4
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad ali Sahraian
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)
Undecided - It is not yet known if there will be 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
Manuscripts will be published based on the project data
When the data will become available and for how long
End of study
To whom data/document is available
For all researchers and clinicians
Under which criteria data/document could be used
Based on the Iran Ministry of Health condition related to clinical trials
From where data/document is obtainable
Deputy of Research and Technology, Tehran University of Medical Sciences, Tehran, Iran
What processes are involved for a request to access data/document