DyslipidemiasPhase 3NCT03133975
Vitamin D Supplementation for Treatment of Dyslipidemia
A Phase 3 study testing Vitamin D3 (Treatment) in people with Dyslipidemias, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Vitamin D3 (Treatment)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 1 Jul 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal females (35-45 years)
Who cannot join
- no co morbodity
- no lipid lowering drugs or contraceptive pills
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Al Mansurah, 35516
Eman O Khashaba, Ass Professor, 01092988444, emankhashaba@mans.edu.eg
Hala El Ashry, professor, 01009172054, halamalek@live.com
About this study
Official title: Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women
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.
Read the 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:
- Serum 25 hydroxy Vitamin D3
- C reactive protein
- Serum Calcium level
- 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
- Conditions
- Dyslipidemias
- Being tested
- Vitamin D3 (Treatment), Mixed diet of carbohydrate and protein (Control)
- Keywords
- high dose vitamin D, dyslipidemia, premenopausal women
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (Treatment)Drug
Also called divarol
Single high dose vitamin D3 in treatment of dyslipedemia
Mixed diet of carbohydrate and protein (Control)Other
Mixed diet of carbohydrate and protein
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Single high dose IM VIT D Receives: Drug: Vitamin D3 (Treatment) |
| Control | Active comparator | Usual diet mix of carbohydrates - lipid - protein - minerals \& vitamins Receives: Other: Mixed diet of carbohydrate and protein (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum levels of LDL-HDL-Total cholesterol-triglecerides
reduction in lipid profile significantly than controls
Measured: 3 months-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial VITAMIN D for treatment of dyslipedemia
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Khashaba, Mansoura University
- Investigators
- Nibal Murad, lectURER, Principal investigator, Mansoura University-Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133975
- Sponsor's protocol ID
- R/17.03.86
- Status last verified
- Aug 2018
- First submitted
- 26 Apr 2017
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation for Reduction of Dyslipidemia in Premenopausal Women
- ClinicalTrials.gov ID
- NCT03133975
- Acronym / sponsor ID
- R/17.03.86
- Conditions
- Dyslipidemias
- Keywords
- high dose vitamin D, dyslipidemia, premenopausal women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Serum 25 hydroxy Vitamin D3
- C reactive protein
- Serum Calcium level
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial VITAMIN D for treatment of dyslipedemia
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Vitamin D3 (Treatment)Single high dose IM VIT D |
| Control | Active comparator | Other: Mixed diet of carbohydrate and protein (Control)Usual diet mix of carbohydrates - lipid - protein - minerals \& vitamins |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- premenopausal females (35-45 years)
Key exclusion criteria (2 listed)
- no co morbodity
- no lipid lowering drugs or contraceptive pills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (Treatment)Also: divarolSingle high dose vitamin D3 in treatment of dyslipedemia | Drug | Treatment |
| Mixed diet of carbohydrate and protein (Control)Mixed diet of carbohydrate and protein | Other | Control |
Primary outcome
serum levels of LDL-HDL-Total cholesterol-triglecerides
Time frame: 3 months-6 months
reduction in lipid profile significantly than controls
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nibal Murad, lectURER principal investigator
Mansoura University-Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 (Treatment) in people with Dyslipidemias, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala Abdel Malek, ass prof (01009172054, halamalek@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum levels of LDL-HDL-Total cholesterol-triglecerides (time frame: 3 months-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.