Vitamin D DeficiencyNCT04307784
The Effects of Vitamin D3 Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control
A study testing VD3, Omega-3FA 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 Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control Read more about this study
- Who is it for?
- Ages 30 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VD3, Omega-3FA and VD3 and Omega-3FA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteJordan
- Study dates
- 10 Mar 2020to 30 Jun 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 30 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged (30-64)
- Have a medical diagnosis of VDD
Who cannot join
- Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
- Documented history of allergic reactions to Omega-3FA supplementations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency
The Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control
Read the detailed description
The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control.
This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD).
This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at the end of the trial.
- Conditions
- Vitamin D Deficiency
- Being tested
- VD3, Omega-3FA, VD3 and Omega-3FA, Control
- Keywords
- Vitamin D Deficiency, vitamin D3, omega-3 fatty acids, glycated Hemoglubine, C-peptide, Insulin resistance, VD3, A1C, HbA1C
- Medical subject headings
- Vitamin D Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VD3Dietary supplement
VD3 (50.000 IU/week) for 8 weeks
Omega-3FADietary supplement
Omaga-3FA (300 mg/day) for 8 weeks
VD3 and Omega-3FADietary supplement
VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
ControlOther
Also called nothing
No intervention is given
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 alone Group | Experimental | Treated with VD3 (50.000 IU/week) Receives: Dietary Supplement: VD3 |
| Omaga-3 alone Group | Experimental | Treated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. Receives: Dietary Supplement: Omega-3FA |
| Vitamin D3 and Omega-3 Combination, Group | Experimental | Treated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. Receives: Dietary Supplement: VD3 and Omega-3FA |
| Control Group | Experimental | No intervention was given. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C
Concentration
Measured: 8 weeks
Secondary outcomes (1)
Plasma Concentration of PTH and Calcium
Concentration
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 posted13 Mar 2020
- Study start10 Mar 2020
- Primary completion10 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 115 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 (ASU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307784
- Sponsor's protocol ID
- DRGS-2014-2015-165-6
- Status last verified
- Jul 2020
- First submitted
- 11 Mar 2020
- 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 underline results in a publication.
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
- The Effects of Vitamin D3 Supplementation Alone and in a Combination With Omega-3 on the Association of C-peptide With Glycemic Control; A Randomized Controlled Trial in People With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT04307784
- Acronym / sponsor ID
- DRGS-2014-2015-165-6
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, vitamin D3, omega-3 fatty acids, glycated Hemoglubine, C-peptide, Insulin resistance, VD3, A1C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Mar 2020 (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 Effects of Vitamin D3 alone and in a combination with omega-3 on the association of C-peptide with glycemic control
Detailed description
The data bout the effects of Vitamin D3 (VD3) alone and as a combination with omega-3 fatty acids (Omega-3FA) on the association between C-peptide (CP) and the glycated hemoglobin (HbA1c) is scarce, conflicting and nothing published in the literature review on the combined effect of VD3 and Omega-3FA as a combination on the association of CP with glycemic control.
This study will be conducted to investigate the effects of (VD3) alone and as a combination with Omega-3FA on the association between CP as an insulin secretion marker, and glycemic control parameters represented by glycated Hemoglobin (HbA1c), on people with vitamin D deficiency (VDD).
This randomized, placebo-controlled trial is designed to test the effects of (50,000 IU VD3/ weekly) and (300mg omega-3FA/daily) separately and as a combination for eight weeks, on the serum levels of CP, 25-hydroxy vitamin D (25OHD) and HbA1c. this study will be carried out during winter on 120 healthy Jordanian males and females with VDD with age range (25-50) years. Fasting serum levels for 25OHD, CP, HbA1c, PTH, Calcium, Phosphate, ALT (Alanine aminotransferase) and Urea were assessed at baseline and at 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 alone Group | Experimental | Dietary Supplement: VD3Treated with VD3 (50.000 IU/week) |
| Omaga-3 alone Group | Experimental | Dietary Supplement: Omega-3FATreated with (1000 mg) wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. |
| Vitamin D3 and Omega-3 Combination, Group | Experimental | Dietary Supplement: VD3 and Omega-3FATreated with 50.000 IU VD3 per week and 1000 mg wild salmon and fish oil complex (contains 300 mg of n-3FA) once daily. |
| Control Group | Experimental | Other: ControlNo intervention was given. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged (30-64)
- Have a medical diagnosis of VDD
Key exclusion criteria (2 listed)
- Chronic diseases, such as (osteoporosis, cancer, kidney disease(due to the association between prolonged administration of VD3 and kidney stones formation), an endocrine disorder, thalassemia).
- Documented history of allergic reactions to Omega-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 (50.000 IU/week) for 8 weeks | Dietary supplement | Vitamin D3 alone Group |
| Omega-3FAOmaga-3FA (300 mg/day) for 8 weeks | Dietary supplement | Omaga-3 alone Group |
| VD3 and Omega-3FAVD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks | Dietary supplement | Vitamin D3 and Omega-3 Combination, Group |
| ControlAlso: nothingNo intervention is given | Other | Control Group |
Primary outcome
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C
Time frame: 8 weeks
Concentration
1 secondary outcome
Plasma Concentration of PTH and 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.
- C-peptide: new findings and therapeutic possibilities.Link provided by the sponsor.
- 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 Private University (ASU)
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-3FA 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 2 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?
Plasma Concentration of 25-hydroxyvitamin D, C-peptide and HbA1C (time frame: 8 weeks). 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 14 Jul 2020.