Vitamin D Supplementation for Treatment of Dyslipidemia

Phase 3

• Conditions: Dyslipidemias
• Interventions: Drug: Vitamin D3 (Treatment); Other: Mixed diet of carbohydrate and protein (Control)

• Registration Number: NCT03133975
• Lead Sponsor: Mansoura University

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:

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

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-04-28
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-17
• Last Update Posted: 2018-08-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• premenopausal females (35-45 years)

Exclusion Criteria

• no co morbodity
• no lipid lowering drugs or contraceptive pills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Vitamin D3 (Treatment)	Single high dose IM VIT D
Control	Mixed diet of carbohydrate and protein (Control)	Usual diet mix of carbohydrates - lipid - protein - minerals \& vitamins

Primary Outcome Measures

Name	Time	Method
serum levels of LDL-HDL-Total cholesterol-triglecerides	3 months-6 months	reduction in lipid profile significantly than controls

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Mansourah, Egypt