Vitamin D DeficiencyNCT04005612
Effect of Vitamin d and Omega 3 on Osteocalcin
A study testing vitamin D3, omega-3 fatty acid and vitamin D3 and omega-3 fatty acid in people with Vitamin D Deficiency, run by Applied Science Private University at 1 site in Jordan.
Trial summary
Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- vitamin D3, omega-3 fatty acid and vitamin D3 and omega-3 fatty acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2019to 1 Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml).
Who cannot join
- People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
- People with bone disorders also excluded.
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 Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels
Read the detailed description
The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.
This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).
This randomized, controlled clinical trial was 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 the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).
This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.
Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .
- Conditions
- Vitamin D Deficiency
- Being tested
- vitamin D3, omega-3 fatty acid, vitamin D3 and omega-3 fatty acid, control
- Keywords
- Vitamin D Deficiency, plama osteocalcin, 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.
vitamin D3Dietary supplement
50,000 IU VD3 / week for 8 weeks
omega-3 fatty acidDietary supplement
300 mg of omega 3-FA once daily for 8 weeks
vitamin D3 and omega-3 fatty acidDietary supplement
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
controlOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| vitamin d3 group | Experimental | weekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks Receives: Dietary Supplement: vitamin D3; Dietary Supplement: omega-3 fatty acid; Dietary Supplement: vitamin D3 and omega-3 fatty acid; Other: control |
| omega3-Fatty Acid group | Experimental | 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily Receives: Dietary Supplement: vitamin D3; Dietary Supplement: omega-3 fatty acid; Dietary Supplement: vitamin D3 and omega-3 fatty acid; Other: control |
| VD3 and Omega-3FA group | Experimental | 50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily Receives: Dietary Supplement: vitamin D3; Dietary Supplement: omega-3 fatty acid; Dietary Supplement: vitamin D3 and omega-3 fatty acid; Other: control |
| Control group | No intervention | NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin d3 levels
Plasma levels of 25-hydroxyvitamin D
Measured: 8 weeks
osteocalcin levels
plasma osteocalcin levels
Measured: 8 weeks
Secondary outcomes (2)
PTH
Plasma concentrations of PTH
Measured: 8 weeks
calcium
plasma Ca levels
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 start1 Nov 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 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
- 120 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 Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005612
- Sponsor's protocol ID
- DRGS-2014-2015-165-3
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
PubMed 18400738
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 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 Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT04005612
- Acronym / sponsor ID
- DRGS-2014-2015-165-3
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, plama osteocalcin, omega-3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 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.
Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels
Detailed description
The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.
This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).
This randomized, controlled clinical trial was 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 the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).
This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.
Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| vitamin d3 group | Experimental | Dietary Supplement: vitamin D3, Dietary Supplement: omega-3 fatty acid, Dietary Supplement: vitamin D3 and omega-3 fatty acid, Other: controlweekly Dietary Supplement: Vitamin D3 50,000 IU Vitamin D3 / week for 8 weeks |
| omega3-Fatty Acid group | Experimental | Dietary Supplement: vitamin D3, Dietary Supplement: omega-3 fatty acid, Dietary Supplement: vitamin D3 and omega-3 fatty acid, Other: control1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily |
| VD3 and Omega-3FA group | Experimental | Dietary Supplement: vitamin D3, Dietary Supplement: omega-3 fatty acid, Dietary Supplement: vitamin D3 and omega-3 fatty acid, Other: control50,000 IU VD3 / week and 1000 mg wild salmon and fish oil complex (contains 300 mg of omega-3 FA) once daily |
| Control group | No intervention | –NO INTERVENTION |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml).
Key exclusion criteria (2 listed)
- People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
- People with bone disorders also excluded.
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 D350,000 IU VD3 / week for 8 weeks | Dietary supplement | VD3 and Omega-3FA group, omega3-Fatty Acid group, vitamin d3 group |
| omega-3 fatty acid300 mg of omega 3-FA once daily for 8 weeks | Dietary supplement | VD3 and Omega-3FA group, omega3-Fatty Acid group, vitamin d3 group |
| vitamin D3 and omega-3 fatty acid50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks | Dietary supplement | VD3 and Omega-3FA group, omega3-Fatty Acid group, vitamin d3 group |
| controlno intervention | Other | VD3 and Omega-3FA group, omega3-Fatty Acid group, vitamin d3 group |
Primary outcome
vitamin d3 levels
Time frame: 8 weeks
Plasma levels of 25-hydroxyvitamin D
osteocalcin levels
Time frame: 8 weeks
plasma osteocalcin levels
2 secondary outcomes
PTH
Time frame: 8 weeks
calcium
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 14 Jul 2020.
- Background: PubMed 18400738Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. doi: 10.1093/ajcn/87.4.1080S.
- Individual participant dataSharing planned: Yes. all IPD that underlie 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 Private 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 vitamin D3, omega-3 fatty acid and vitamin D3 and omega-3 fatty acid 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 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: finished, as of the sponsor's last update on 14 Jul 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?
vitamin d3 levels (time frame: 8 weeks). The study lists 2 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 NCT04005612, 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 14 Jul 2020.