Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03133975
Other study ID # R/17.03.86
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Completed NCT04894318 - The Effect Of Low-Fat And Low-Cholesterol Dietary Intervention On LDL Sub-Groups In Turkısh Dyslipidemic Patients N/A
Completed NCT04862962 - Study to Evaluate the Safety of the Fixed-dose Combination Rosuvastatin/Ezetimibe for Patients With Dyslipidaemia
Completed NCT04052594 - A Study of LY3475766 in Healthy Participants Phase 1
Active, not recruiting NCT04270084 - Metabolic Optimization Through Diet/Lifestyle Improvements For Youth N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04516291 - A Dose-Ranging Study With Vupanorsen (TRANSLATE-TIMI 70) Phase 2
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A
Completed NCT04186780 - Effects of Lentinula Edodes Bars on Dyslipidemia and Oxidative Stress in Cholesterol Individuals: Randomized Study N/A
Not yet recruiting NCT03674333 - Effect of Adding Folic Acid on Lipid Parameters in Population With Dyslipidemias N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Terminated NCT01697735 - The Therapeutic Effects of Statins and Berberine on the Hyperlipemia Phase 4
Completed NCT00362908 - Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome N/A
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Completed NCT00644709 - A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD) Phase 4
Recruiting NCT05624658 - Effect of Combined Lipid-lowering Therapy on Atherosclerotic Plaque Vulnerability in Patients With ACS N/A
Recruiting NCT03988101 - Role of Statin in Venous Dysfunction in Patients With Venous Thromboembolism Event Phase 4
Recruiting NCT06024291 - Reducing Circulating Sphingolipid Levels to Optimise Cardiometabolic Health - The SphingoFIT Trial N/A
Completed NCT01218204 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin Phase 2