25-hydroxyvitamin D Levelsn-3FAon25OHDNCT04174625
The Effect of Omega 3 on 25 Hydroxyvitamin D
A study testing Dietary Supplement: Omega3-FA in people with 25-hydroxyvitamin D Levels, run by Applied Science Private University at 1 site in Jordan.
Trial summary
The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels. Read more about this study
- Who is it for?
- Ages 22 to 66 yearsHealthy volunteers can take part
- Conditions the study is for
- 25-hydroxyvitamin D Levels
- What is being tested?
- Dietary Supplement: Omega3-FA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- 25 Nov 2020to 15 Dec 2021
- 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 66 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Male and female Jordanian ASU students and employees who live in Amman.
- Informed written consent from the participant prior to the start of the study.
- a serum 25(OH)D concentration between 10 and 70 ng/mL.
Who cannot join
- Any eligiable subject refuses to apply with informed written consent before the start of the study.
- Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems.
- Who are receiving vitamin D3 supplements (3 months before the start of the study) .
- Pregnants,Breastfeeding females ,Females using hormonal contraceptives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega 3 Supplementations on Serum 25 Hydroxyvitamin D Levels
The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.
Read the detailed description
No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in Jordanian men and women.
This study was designed to investigate whether omega 3 supplementation has a potential effect on the reducing of serum 25-hydroxyvitamin D levels.
This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver and kidney functions will be assayed.
- Conditions
- 25-hydroxyvitamin D Levels
- Being tested
- Dietary Supplement: Omega3-FA
- Keywords
- omega 3, 25 hydroxyvitamin D, 25OHD, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Omega3-FADietary supplement
Also called n-3FA
Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omega3-FA group | Experimental | Omega3-FA group 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily Receives: Dietary Supplement: Dietary Supplement: Omega3-FA |
| Control group | Experimental | VD3 group 50,000 IU/week Receives: Dietary Supplement: Dietary Supplement: Omega3-FA |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum concentrations of 25-hydroxyvitamin D
ng/ml
Measured: 8 weeks
serum concentrations of PTH
pg/mL
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 posted22 Nov 2019
- Study start25 Nov 2020
- Primary completion17 Jul 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 25-hydroxyvitamin D LevelsStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Suleiman Abu-Samak, Applied Science Private University
- Investigators
- Mahmoud S Abu-Samak, PhD, Principal investigator, Department of Clinical Pharmacy and Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174625
- Sponsor's protocol ID
- DRGS-2014-2015-165-5
- Acronym
- n-3FAon25OHD
- Status last verified
- Feb 2022
- First submitted
- 20 Nov 2019
- Last updated
- 24 Feb 2022
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega 3 Supplementations on Serum 25 Hydroxyvitamin D Levels
- ClinicalTrials.gov ID
- NCT04174625
- Acronym / sponsor ID
- n-3FAon25OHD / DRGS-2014-2015-165-5
- Conditions
- 25-hydroxyvitamin D Levels
- Keywords
- omega 3, 25 hydroxyvitamin D, 25OHD, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 17 Jul 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 22 Nov 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 effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.
Detailed description
No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in Jordanian men and women.
This study was designed to investigate whether omega 3 supplementation has a potential effect on the reducing of serum 25-hydroxyvitamin D levels.
This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver and kidney functions will be assayed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega3-FA group | Experimental | Dietary Supplement: Dietary Supplement: Omega3-FAOmega3-FA group 1000 mg wild salmon and fish oil complex (contains 300 mg of omega3-FA) once daily |
| Control group | Experimental | Dietary Supplement: Dietary Supplement: Omega3-FAVD3 group 50,000 IU/week |
Who may qualify
- Ages
- 22 to 66 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Male and female Jordanian ASU students and employees who live in Amman.
- Informed written consent from the participant prior to the start of the study.
- a serum 25(OH)D concentration between 10 and 70 ng/mL.
Key exclusion criteria (4 listed)
- Any eligiable subject refuses to apply with informed written consent before the start of the study.
- Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems.
- Who are receiving vitamin D3 supplements (3 months before the start of the study) .
- Pregnants,Breastfeeding females ,Females using hormonal contraceptives
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 |
|---|---|---|
| Dietary Supplement: Omega3-FAAlso: n-3FADietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks | Dietary supplement | Control group, Omega3-FA group |
Primary outcome
serum concentrations of 25-hydroxyvitamin D
Time frame: 8 weeks
ng/ml
serum concentrations of PTH
Time frame: 8 weeks
pg/mL
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 24 Feb 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for 25-hydroxyvitamin D Levels
Recruiting
Cholecalciferol and Calcifediol Are Both Useful to Improve Vitamin D Serum Levels
Hypovitaminosis D
Recruiting
Early Vitamin D3 Supplementation for Critically Ill Patients
Vitamin D Deficiency, Critical Illness
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
Department of Clinical Pharmacy and Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Omega3-FA in people with 25-hydroxyvitamin D Levels, 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 4 inclusion and 4 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 24 Feb 2022. 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?
serum concentrations of 25-hydroxyvitamin D (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?
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 24 Feb 2022.