Vitamin D Supplementation for Treatment of Dyslipidemia

Dyslipidemias Clinical Trial

Official title:

Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03133975
• Other study ID #: R/17.03.86
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2018
• Source: Mansoura University
• Contact: Hala Abdel Malek, ass prof
• Phone: 01009172054
• Email: halamalek[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• premenopausal females (35-45 years)

Exclusion Criteria:

• no co morbodity

• no lipid lowering drugs or contraceptive pills

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum levels of LDL-HDL-Total cholesterol-triglecerides	reduction in lipid profile significantly than controls	3 months-6 months