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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.
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)
There is possible recruiting of postmenopausal women according to difficulty in finding pre-menopausal women.
Methods: study patients will be subjected to:
Outcome that will be measured before and after follow up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Single high dose IM VIT D |
|
| Control | Active Comparator | Usual diet mix of carbohydrates - lipid - protein - minerals & vitamins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 (Treatment) | Drug | Single high dose vitamin D3 in treatment of dyslipedemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum levels of LDL-HDL-Total cholesterol-triglecerides | reduction in lipid profile significantly than controls | 3 months-6 months |
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Inclusion Criteria:
Exclusion Criteria:
to highlight the effect on females as it is more common among premenopausal women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hala Abdel Malek, ass prof | Contact | 01009172054 | halamalek@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Nibal Murad, lectURER | Mansoura University-Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Recruiting | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D013812 | Therapeutics |
| D011506 | Proteins |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomized clinical trial VITAMIN D for treatment of dyslipedemia
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double blinded
| Mixed diet of carbohydrate and protein (Control) | Other | Mixed diet of carbohydrate and protein |
|
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D000602 | Amino Acids, Peptides, and Proteins |