Vitamin D Supplementation for Treatment of Dyslipidemia

Study Overview
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Brief Summary
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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
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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

Official Title
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Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Vitamin D3 (Treatment)
* Other: Mixed diet of carbohydrate and protein (Control)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: premenopausal females (35-45 years) Exclusion Criteria: no co morbodity no lipid lowering drugs or contraceptive pills

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial VITAMIN D for treatment of dyslipedemia
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Single high dose IM VIT D | Drug: Vitamin D3 (Treatment)<br>* Single high dose vitamin D3 in treatment of dyslipedemia<br>* Other names: divarol;|
| Active Comparator: Control<br>Usual diet mix of carbohydrates - lipid - protein - minerals & vitamins | Other: Mixed diet of carbohydrate and protein (Control)<br>* Mixed diet of carbohydrate and protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of LDL-HDL-Total cholesterol-triglecerides | reduction in lipid profile significantly than controls | 3 months-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high dose vitamin D, dyslipidemia, premenopausal women