The main goal of the study is comparing effect of high dose vitamin D and placebo on stress-induced hyperglycemia in critically ill patients.
Fifty patients with diagnosis of stress-induced hyperglycemia during the first 24 hours of ICU admission will be recruited.
Included patients will be assigned to vit D or placebo group based on the block randomization method. Patients in the vit D and placebo group will receive either 600000 IU vitamin D3 or placebo as single IM injection respectively at time of diagnosis of stress-induced hyperglycemia.
Vitamin D3 as 300000 IU ampule and its placebo will be prepared by Darou-Pakhsh Pharmaceutical Company, Tehran, Iran.
A 10-ml venous blood sample will be collected from each patient at baseline (at admission time before intervention) and at day 7. Serum levels of 25 (OH) vitamin D3, adiponectin, glucose and insulin will be measured within these samples. In addition HOMA-IR (Homeostasis Model Assessment-Insulin Resistance) will be calculated for all the patients at baseline and day 7.
Finally, based on the collected data, effect of vitamin D and placebo administration on the serum levels of vitamin D, adiponectin (as a marker of insulin resistance), HOMA-IR will be compared at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014061218069N1
Registration date:2014-10-06, 1393/07/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-06, 1393/07/14
Registrant information
Name
Nafiseh Sadat Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4446 2652
Email address
n-alizadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-03-30, 1393/01/10
Expected recruitment end date
2016-03-29, 1395/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of high dose vitamin D and placebo on insulin resistance in critically ill patients
Public title
Effect of high dose vitamin D on blood glucose in critically ill patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
- Critically ill patients aged between 18-65 years old with diagnosis of stress-induced hyperglycemia during the first 24 hours of intensive care unit (ICU) admission will be recruited.
Exclusion criteria:
Patients with following characteristics will be excluded: Diabetic patients, hemoglobin (Hbg) A1C>7.5, positive history of hypersensitivity to vitamin D or its analogues, hypercalcemia, any contraindication for intramuscular (IM) injection, current use of corticosteroids or any drugs affecting patients’ blood glucose.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Included patients will be assigned to the intervention (Vit D) or placebo group based on the block randomization method. Vitamin D and its placebo will be prepared by the pharmaceutical company with same packaging and drug formulation properties. The researchers, ICU physicians and patients are blinded and drug will be distributed by the hospital pharmacy department.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave. Tehran, Iran
City
Tehran
Postal code
Approval date
2014-03-10, 1392/12/19
Ethics committee reference number
93-2-33-25718
Health conditions studied
1
Description of health condition studied
Hyperglycemia
ICD-10 code
R73
ICD-10 code description
Elevated blood glucose level
Primary outcomes
1
Description
Plasma insulin
Timepoint
During 24 hours of ICU admission and 7 days after intervention
Method of measurement
Elisa kit
2
Description
Plasma glucose
Timepoint
During 24 hours of ICU admission and 7 days after intervention
Method of measurement
Elisa Kit
3
Description
Serum level of 25 (OH) vitamin D3
Timepoint
During 24 hours of ICU admission and 7 days after intervention
Method of measurement
Elisa kit
4
Description
Adiponectin
Timepoint
During 24 hours of ICU admission and 7 days after intervention
Method of measurement
Elisa kit
Secondary outcomes
empty
Intervention groups
1
Description
Single IM injection of 600000 IU vitamin D3 in intervention group (Two 300000 IU vitamin D3 ampules , each one contains 1 ml of drug)
Category
Treatment - Drugs
2
Description
IM injection of 2 placebo ampules (each one contains 1 ml Placebo)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr Hossein Khalili
Street address
Keshavarz AVE, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nafiseh Sadat Alizadeh
Position
Pharm.D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
nafisehalizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Nafiseh Sadat Alizadeh
Position
Pharm. D
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
nafisehalizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)