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Vitamin D Supplementation for Treatment of Dyslipidemia

Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03133975
Enrollment
30
Registered
2017-04-28
Start date
2017-04-01
Completion date
2019-07-01
Last updated
2018-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Keywords

high dose vitamin D, dyslipidemia, premenopausal women

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

Interventions

DRUGVitamin D3 (Treatment)

Single high dose vitamin D3 in treatment of dyslipedemia

OTHERMixed diet of carbohydrate and protein (Control)

Mixed diet of carbohydrate and protein

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blinded

Intervention model description

Randomized clinical trial VITAMIN D for treatment of dyslipedemia

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* premenopausal females (35-45 years)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
serum levels of LDL-HDL-Total cholesterol-triglecerides3 months-6 monthsreduction in lipid profile significantly than controls

Countries

Egypt

Contacts

Primary ContactHala Abdel Malek, ass prof
halamalek@live.com01009172054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026