Vitamin D Supplementation for Treatment of Dyslipidemia
Primary Purpose
Dyslipidemias
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D3 (Treatment)
Mixed diet of carbohydrate and protein (Control)
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias focused on measuring high dose vitamin D, dyslipidemia, premenopausal women
Eligibility Criteria
Inclusion Criteria:
- premenopausal females (35-45 years)
Exclusion Criteria:
- no co morbodity
- no lipid lowering drugs or contraceptive pills
Sites / Locations
- Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment
Control
Arm Description
Single high dose IM VIT D
Usual diet mix of carbohydrates - lipid - protein - minerals & vitamins
Outcomes
Primary Outcome Measures
serum levels of LDL-HDL-Total cholesterol-triglecerides
reduction in lipid profile significantly than controls
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03133975
Brief Title
Vitamin D Supplementation for Treatment of Dyslipidemia
Official Title
Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will be conducted to Assess possible reduction in lipid profile (LDL-Triglecerides-cholesterol) among pre-menopausal women in vit D group compared to standard treatment group after 3 months & 6 month of follow up as prophylaxis step for atherosclerosis.
Detailed Description
Vitamin D receptor gene mutations have been associated with increased incidence of arterial hypertension. While, hyperlipidemia and lipoprotein oxidation in bone is leading to osteoporosis by inhibiting osteoblastic differentiation It has been reported that vitamin D supplementation has shown pro-atherogenic effects in rats, and its deficiency is associated with the deterioration of atherogenesis These contradictory findings on the progression of atherosclerosis were examined in this study.
Aim: This study will be conducted to assess possible reduction in lipid profile (LDL-Triglycerides-cholesterol) among pre-menopausal women in vitamin D group compared to standard treatment group after 3 months & 6 month of follow up as prophylaxis step for atherosclerosis.
Subject and methods: Randomized clinical trial with double blinding will be performed on two groups study group and control group. The cases will recruited from outpatient clinic of medicine department in Mansoura university Hospital.
Sample size: based on pilot study after start of trial
Study groups:
Intervention group: High dose vitamin D3 IM treatment group according to vitamin D3 level after laboratory assessment.
Standard treatment group: Balanced diet mix of Carbohydrate, lipid, protein and fat diet minerals and vitamins for same period of follow up.
Inclusion criteria : pre-menopausal females (35-45 years old)
No co morbidity
Negative history of contraceptive pills or drug history of cholesterol lowering drugs
Absent chronic diseases
There is possible recruiting of postmenopausal women according to difficulty in finding pre-menopausal women.
Methods: study patients will be subjected to:
Full history taking,clinical examination, Anthropometric measurements.
Laboratory investigations: Vitamin D3 assessment for all study patients.
Outcome that will be measured before and after follow up:
Serum 25 hydroxy Vitamin D3
C reactive protein
Serum Calcium level
Complete Lipid profile: LDL-HDL-Triglycerides -Total cholesterol quantitative and qualitative assessment.Patient will be fasting for at least 12-14 h then 5 mL venous blood sample will be drawn from each patient into plain tube and left to clot. Serum for routine analysis and the other aliquot will be stored at -21°C analysis will be separated by centrifugation into two aliquots; one will be used
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
Keywords
high dose vitamin D, dyslipidemia, premenopausal women
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial VITAMIN D for treatment of dyslipedemia
Masking
ParticipantInvestigator
Masking Description
double blinded
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Single high dose IM VIT D
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual diet mix of carbohydrates - lipid - protein - minerals & vitamins
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 (Treatment)
Other Intervention Name(s)
divarol
Intervention Description
Single high dose vitamin D3 in treatment of dyslipedemia
Intervention Type
Other
Intervention Name(s)
Mixed diet of carbohydrate and protein (Control)
Intervention Description
Mixed diet of carbohydrate and protein
Primary Outcome Measure Information:
Title
serum levels of LDL-HDL-Total cholesterol-triglecerides
Description
reduction in lipid profile significantly than controls
Time Frame
3 months-6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
to highlight the effect on females as it is more common among premenopausal women
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premenopausal females (35-45 years)
Exclusion Criteria:
no co morbodity
no lipid lowering drugs or contraceptive pills
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hala Abdel Malek, ass prof
Phone
01009172054
Email
halamalek@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nibal Murad, lectURER
Organizational Affiliation
Mansoura University-Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Mansourah
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman O Khashaba, Ass Professor
Phone
01092988444
Email
emankhashaba@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Hala El Ashry, professor
Phone
01009172054
Email
halamalek@live.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Vitamin D Supplementation for Treatment of Dyslipidemia
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