In this randomized single-blind study without placebo control, the effect of calcium-vitamin D supplementation on serum lipid levels of 100 women 50-75 years old with cholesterol of 200-239 and triglyceride of 150-199 and LDL of 100-159 and vitamin D level less than 30 ng/mL will be investigated. In case of hyperlipidemia, diabetes, heart disease and thyroid diseases, patients are excluded. First, the patient’s BMI and waist circumference are calculated. The patients are given Calcium-vitamin D supplement tablets made by Tehran shimi pharmaceutical manufacturing Co. twice-daily (containing 500 mg calcium and 200 IU vitamin D) before breakfast and before lunch for 6 months. Then, blood lipid levels will be recorded after 3 and 6 months. The patient's weight, height and waist circumference are recorded at the end of 6 months and compared with initial data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017020532406N1
Registration date:2017-03-01, 1395/12/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Maryam Javadian Kootenaei
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 2334
Email address
m.javadian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Babol University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Calcium-vitamin D supplementation on serum lipids levels of 50-75 years old women
Public title
Effect of Calcium-vitamin D supplementation on serum lipids levels of 50-75 years old women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not using calcium-vitamin D supplementation, normal thyroid hormone levels, satisfaction for participating in study.
Exclusion criteria: underlying disease such as hyperlipidemia, diabetes, heart disease, atorvastatin consymption
Age
From 50 years old to 75 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Babol University of Medical sciences, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
MUBABOL.REC.1395.183
Health conditions studied
1
Description of health condition studied
Hyperlipidaemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidaemia, unspecified
Primary outcomes
1
Description
HDL
Timepoint
Baseline
Method of measurement
mg/dL
2
Description
LDL
Timepoint
Baseline
Method of measurement
mg/dL
3
Description
TG
Timepoint
Baseline
Method of measurement
mg/dL
4
Description
25 Hydroxy vitamin D
Timepoint
Baseline
Method of measurement
ng/mL
5
Description
BMI
Timepoint
Baseline
Method of measurement
kg/m2
6
Description
waist circumference
Timepoint
Baseline
Method of measurement
cm
Secondary outcomes
empty
Intervention groups
1
Description
The patients are given Calcium-vitamin D supplement tablets made by Tehran shimi pharmaceutical manufacturing Co. twice-daily (containing 500 mg calcium and 200 IU vitamin D) before breakfast and before lunch for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics Clinic of Ayatollah Rouhani Hospital of Babol
Full name of responsible person
Maryam Javadian, MD
Street address
Ayatollah Rouhani Hospital, Ganjafroz avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Ali Akbar Moghadamnia, MD
Street address
Vice Chancellor for Research and Technology, Babol University of Medical sciences, Gangafroz Avenue
City
Babol
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 and Technology, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Maryam Javadian, MD
Position
Obstetrician
Other areas of specialty/work
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 2229 4718
Fax
Email
m.javadian@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical sciences
Full name of responsible person
Shahla Yazdani, MD
Position
Obstetrician
Other areas of specialty/work
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 2229 4718
Fax
Email
shahla_yazdani_1348@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roya Gharoei, MD
Position
Resident of Obstetrics & Gynecology
Other areas of specialty/work
Street address
Babol University of Medical sciences, Gangafroz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)