Vitamin D Supplementation for Treatment of Dyslipidemia
NCT ID: NCT03133975
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2017-04-01
2019-07-01
Brief Summary
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Detailed Description
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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:
1. Serum 25 hydroxy Vitamin D3
2. C reactive protein
3. Serum Calcium level
4. 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
Single high dose IM VIT D
Vitamin D3 (Treatment)
Single high dose vitamin D3 in treatment of dyslipedemia
Control
Usual diet mix of carbohydrates - lipid - protein - minerals \& vitamins
Mixed diet of carbohydrate and protein (Control)
Mixed diet of carbohydrate and protein
Interventions
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Vitamin D3 (Treatment)
Single high dose vitamin D3 in treatment of dyslipedemia
Mixed diet of carbohydrate and protein (Control)
Mixed diet of carbohydrate and protein
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* no lipid lowering drugs or contraceptive pills
35 Years
45 Years
FEMALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Eman Khashaba
Lecturer in Industrial Medicine
Principal Investigators
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Nibal Murad, lectURER
Role: PRINCIPAL_INVESTIGATOR
Mansoura University-Faculty of Medicine
Locations
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Faculty of Medicine
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R/17.03.86
Identifier Type: -
Identifier Source: org_study_id
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