Comparison of combination therapy with vitamin D, calcium and statin with statin alone in reducing blood cholesterol in patients with hypercholesterolemia
This study aims to evaluate the effectiveness of supplemental vitamin D3 and calcium in addition to standard treatment (Statin therapy) for treatment of hypercholesterolemia.
Design
In this study, 80 new-case of hypercholesterolemia, who refered to internal medicine clinic in Army hospital were recruited. This study was a crossover study and we had no control group. All interventions were performed on a single group of patients.
Settings and conduct
At first all patients were treated with Atorvastatin, 20 mg, daily and lipid profile was checked after 6 weeks. In second phase, participant received vitamin D3, 400 IU, daily and Calcium, 1 gr, daily in addition to 20 mg Atorvastatin for 6 weeks. Thereafter, lipid profile was rechecked for all patients. Finally, before and after lipid profile measures were compared. We had no blinding in this study.
Participants/Inclusion and exclusion criteria
Patients who had WHO criteria for hypercholesterolemia were included in this study. Patients who had been administered lipid-lowering agents in last one month and supplemental vitamin D3 and calcium in last six months were excluded form study.
Intervention groups
400 IU oral vitamin D3 daily and 1 gr oral Calcium daily for 6 weeks
Main outcome variables
1. Triglyceride
2. Total cholesterol
3. LDL
4. HDL
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036613N1
Registration date:2018-01-03, 1396/10/13
Registration timing:retrospective
Last update:2018-01-03, 1396/10/13
Update count:0
Registration date
2018-01-03, 1396/10/13
Registrant information
Name
Ali Sanjari Moghaddam
Name of organization / entity
Shahid Beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9770
Email address
alisanjarimoghaddam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Aja University of Medical Science
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
2016-11-10, 1395/08/20
Actual recruitment end date
2017-06-10, 1396/03/20
Trial completion date
empty
Scientific title
Comparison of combination therapy with vitamin D, calcium and statin with statin alone in reducing blood cholesterol in patients with hypercholesterolemia
Public title
Effect of vitamin D3 and calcium on blood lipid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
LDL above 160 mg/dl without or with one of cardiovascular risk factors.
LDL above 130 mg/dl with two or more cardiovascular risk factors.
LDL above 100 mg/dl in diabetics and patients with history of CVD.
Total cholesterol above 240.
Exclusion criteria:
Triglyceride above 400 mg/dl.
Taking Lipid-lowering agent within one month before recruitment.
Supplementary calcium and vitamin D in last 6 months.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
65
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Aja University of Medical Sciences
Street address
Aja University of Medical Sciences, Etemadzadeh avenue., Fatemi street., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.AJAUMS.REC.1395.23
Health conditions studied
1
Description of health condition studied
hypercholesterolemia
ICD-10 code
E78.0
ICD-10 code description
Pure hypercholesterolaemia
Primary outcomes
1
Description
Triglyceride
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Lab test
2
Description
HDL
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Lab test
3
Description
Total cholestrol
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Lab test
4
Description
LDL
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Lab test
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Sphygmomanometer
2
Description
Body mass index
Timepoint
Before intervention, 6 weeks after first intervention and 6 weeks after second intervention
Method of measurement
Standing scale for weight and tape for height
Intervention groups
1
Description
At first, all patients were treated by Atorvastatin 20 mg once daily for six weeks. The second intervention in all patients was adding vitamin D3, 400 IU/day and calcium, 1gr/day (CalTrex capsule once per 12 hour) to prior regimen for six weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Internal medicine clinic, 501 Army hospital
Full name of responsible person
Ali Sanjari Moghaddam
Street address
Aja University of Medical Sciences, Etemadzadeh Ave., Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2959
Email
info@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Aja University of Medical Sciences
Full name of responsible person
Dr. Armin Zareian
Street address
Aja University of Medical Sciences, Etemadzadeh Ave., Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2959
Email
info@ajaums.ac.ir
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, Aja 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
Aja University of Medical Sciences
Full name of responsible person
Ali Sanjari Moghaddam
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Aja University of Medical Sciences, Etemadzadeh Ave., Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 218802835055
Fax
Email
alisanjarimoghaddam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Shahnaz tofangciha
Position
MD
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Aja University of Medical Sciences, Etemadzadeh St., Fatemi Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 218802835055
Fax
Email
stofangchiha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Aja University of Medical Sciences
Full name of responsible person
Ali Sanjari Moghaddam
Position
MD
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Aja University of Medical Sciences, Etemadzadeh Ave., Fatemi St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 218802835055
Fax
Email
alisanjarimoghaddam@yahoo.com
Web page address
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
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
Title and more details about the data/document
individual participant data collected for the primary and secondary outcome measure
When the data will become available and for how long
َAfter publication for one year
To whom data/document is available
for all people who request for data
Under which criteria data/document could be used
all types of analysis all allowed. But, use of data for publication is not allowed.
From where data/document is obtainable
corresponding author of article
What processes are involved for a request to access data/document
after request to corresponding author, data will send within one week.