NCT03133975

Vitamin D Supplementation for Treatment of Dyslipidemia

Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 35 Years – 45 Years
• Healthy volunteers: Not accepted

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: 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

• Dyslipidemias

Interventions

Type	Name	Description
DRUG	Vitamin D3 (Treatment)	Single high dose vitamin D3 in treatment of dyslipedemia
OTHER	Mixed diet of carbohydrate and protein (Control)	Mixed diet of carbohydrate and protein

Timeline

• Start date: 2017-04-01
• Primary completion: 2018-12-31
• Completion: 2019-07-01
• First posted: 2017-04-28
• Last updated: 2018-08-21

Locations

1 site across 1 country: Egypt