Vitamin D DeficiencyNCT04005573
The Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein
A study testing VD3, omega 3- FA and VD3 and omega- 3FA in people with Vitamin D Deficiency, run by Applied Science Private University at 1 site in Jordan.
Trial summary
The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency Read more about this study
- Who is it for?
- Ages 22 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VD3, omega 3- FA and VD3 and omega- 3FA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteJordan
- Study dates
- 10 Jul 2019to 1 Jan 2020
- Phase
- Interventional
- 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 22 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
Who cannot join
- Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency
Read the detailed description
Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.
This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein
- Conditions
- Vitamin D Deficiency
- Being tested
- VD3, omega 3- FA, VD3 and omega- 3FA, no intervention
- Keywords
- vitamin D3, Vitamin D Deficiency, Lipid profile, oxidized low density Lipoprotein, omega-3 fatty acids
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VD3Dietary supplement
VD3 50000 IU/ week for 8 weeks
omega 3- FADietary supplement
Omega 3 FA group 300 mg once daily for 8 weeks
VD3 and omega- 3FADietary supplement
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
no interventionOther
no intervention is given
| Study group | Role | What they receive |
|---|---|---|
| VD3 group | Experimental | dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks Receives: Dietary Supplement: VD3 |
| omega 3- FA group | Experimental | dietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks Receives: Dietary Supplement: omega 3- FA |
| VD3 and omega 3 FA group | Experimental | dietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks Receives: Dietary Supplement: VD3 and omega- 3FA |
| control group | Other | no intervention was given Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
VD 3
Serum level of 25-hydroxyvitamin D
Measured: 8 weeks
Total Cholesterol
serum level of total cholesterol
Measured: 8 weeks
HDL Cholesterol
serum level of HDL Cholesterol
Measured: 8 weeks
LDL Cholesterol
serum level of LDL Cholesterol
Measured: 8 weeks
triglycerides
serum level of triglycerides
Measured: 8 weeks
oxidized LDL
serum level of oxidized LDL
Measured: 8 weeks
Secondary outcomes (2)
PTH
serum level of PTH
Measured: 8 weeks
Calcium and Phosphorus
serum level of Calcium and Phosphorus
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start10 Jul 2019
- Primary completion1 Nov 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahmoud S Abu-Samak, PhD, Principal investigator, Applied science university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005573
- Sponsor's protocol ID
- DRGS-2014-2015-165-2
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underline results in a publication
Publications
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
PubMed 21986389
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Lipid Profile Levels and Oxidized Low Density Lipoprotein: a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT04005573
- Acronym / sponsor ID
- DRGS-2014-2015-165-2
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D3, Vitamin D Deficiency, Lipid profile, oxidized low density Lipoprotein, omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 2 Jul 2019 (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.
The combined effect of omega-3 fatty acid and vitamin D3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin D deficiency
Detailed description
Nothing is published in the literature about the combined effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on on lipid profile levels and oxidized low density lipoprotein
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on lipid profile levels and oxidized low density lipoprotein in Jordanian people with vitamin D deficiency.
This randomized, controlled clinical trial will be designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VD3 group | Experimental | Dietary Supplement: VD3dietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks |
| omega 3- FA group | Experimental | Dietary Supplement: omega 3- FAdietary supplement : omega 3- FA group 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks |
| VD3 and omega 3 FA group | Experimental | Dietary Supplement: VD3 and omega- 3FAdietary supplement : VD3 and omega-3FA 50000 IU VD3/week for 8 weeks and 1000 mg wild salmon and fish oil complex (contain 300 mg of omega 3-FA) once daily for 8 weeks |
| control group | Other | Other: no interventionno intervention was given |
Who may qualify
- Ages
- 22 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Jordanian people aged 25-55 medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
Key exclusion criteria (1 listed)
- Subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3FA supplementations
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 |
|---|---|---|
| VD3VD3 50000 IU/ week for 8 weeks | Dietary supplement | VD3 group |
| omega 3- FAOmega 3 FA group 300 mg once daily for 8 weeks | Dietary supplement | omega 3- FA group |
| VD3 and omega- 3FA50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks | Dietary supplement | VD3 and omega 3 FA group |
| no interventionno intervention is given | Other | control group |
Primary outcome
VD 3
Time frame: 8 weeks
Serum level of 25-hydroxyvitamin D
Total Cholesterol
Time frame: 8 weeks
serum level of total cholesterol
HDL Cholesterol
Time frame: 8 weeks
serum level of HDL Cholesterol
LDL Cholesterol
Time frame: 8 weeks
serum level of LDL Cholesterol
triglycerides
Time frame: 8 weeks
serum level of triglycerides
oxidized LDL
Time frame: 8 weeks
serum level of oxidized LDL
2 secondary outcomes
PTH
Time frame: 8 weeks
Calcium and Phosphorus
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 21986389Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
- Individual participant dataSharing planned: Yes. all IPD that underline results in a publication
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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.
Mahmoud S Abu-Samak, PhD principal investigator
Applied science university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VD3, omega 3- FA and VD3 and omega- 3FA in people with Vitamin D Deficiency, run by Applied Science Private University at 1 site in Jordan.
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 1 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: finished, as of the sponsor's last update on 13 Jan 2020. 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 Jordan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VD 3 (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04005573, which also lists 1 linked publication.
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 13 Jan 2020.