Clinical trial NCT03133975: Vitamin D Supplementation for Treatment of Dyslipidemia
Official title: Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dyslipidemias
Keywords: high dose vitamin D
dyslipidemia
premenopausal women
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial VITAMIN D for treatment of dyslipedemia
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* premenopausal females (35-45 years)

Exclusion Criteria:

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

Primary outcomes:
measure: serum levels of LDL-HDL-Total cholesterol-triglecerides
timeFrame: 3 months-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Mansoura University-Faculty of Medicine
name: Nibal Murad, lectURER
role: PRINCIPAL_INVESTIGATOR
References: