Vitamin D DeficiencyNCT03735303
Effect of Vitamin D3 and Omega-3FA on Leptin and HbA1C With Vitamin D Deficiency
A study testing VD3 group, omega 3 FA group and VD3 and omega- 3FA group in people with Vitamin D Deficiency, run by Applied Science Private University at 1 site in Jordan.
Trial summary
The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- VD3 group, omega 3 FA group and VD3 and omega- 3FA group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteJordan
- Study dates
- 1 Dec 2018to 1 Jun 2019
- 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 25 to 55 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
- Blood disorders including
- thalassemia
- sickle cell disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.
The Combined effect of Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.
Read the detailed description
Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels 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 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .
- Conditions
- Vitamin D Deficiency
- Being tested
- VD3 group, omega 3 FA group, VD3 and omega- 3FA group, control group
- Keywords
- vitamin D3, vitamin D deficiency, leptin, A1C, omega-3 fatty acid
- 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.
VD3 groupDietary supplement
VD3 50000 IU/ week for 8 weeks
omega 3 FA groupDietary supplement
omega 3 FA group 300 mg once daily for 8 weeks
VD3 and omega- 3FA groupDietary supplement
50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
control groupOther
no intervention was 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 group |
| 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 group |
| 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 group |
| control group | Experimental | no intervention was given Receives: Other: control group |
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
leptin
serum level of leptin
Measured: 8 weeks
HbA1C
plasma concentration of HbA1C
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 posted8 Nov 2018
- Study start1 Dec 2018
- Primary completion1 Mar 2019
- Study completion1 Jun 2019
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 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
- NCT03735303
- Sponsor's protocol ID
- DRGS-4-2018
- Status last verified
- Dec 2018
- First submitted
- 7 Nov 2018
- Last updated
- 17 Jul 2019
- 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
Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.
PubMed 21492489
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Vitamin D3 and Omega-3 Supplements on Serum Leptin and Glycated Hemoglobin (Hb A1C) Levels in Jordanian People With Vitamin D Deficiency.
- ClinicalTrials.gov ID
- NCT03735303
- Acronym / sponsor ID
- DRGS-4-2018
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D3, vitamin D deficiency, leptin, A1C, omega-3 fatty acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 8 Nov 2018 (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 Vitamin D3 and Omega-3 supplements on serum leptin and Glycated hemoglobin (Hb A1C) levels in Jordanian people with vitamin D deficiency.
Detailed description
Nothing is published in the literature about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum leptin and glycated hemoglobin ( HbA1C)
This study will be conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum leptin and Glycated hemoglobin (Hb A1C) levels 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 1000 mg omega-3FA daily for eight weeks, separately and with each other, on on serum leptin and Glycated hemoglobin (Hb A1C) levels .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VD3 group | Experimental | Dietary Supplement: VD3 groupdietary supplement : VD3 group treated with 50000 IU VD3/ week for 8 weeks |
| omega 3- FA group | Experimental | Dietary Supplement: omega 3 FA groupdietary 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- 3FA groupdietary 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 | Experimental | Other: control groupno intervention was given |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- jordanian people aged 25-55
- medical diagnosis of vitamin D deficiency ( VD <25 ng/ ml)
Key exclusion criteria (3 listed)
- Blood disorders including
- thalassemia
- sickle cell disease
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 |
|---|---|---|
| VD3 groupVD3 50000 IU/ week for 8 weeks | Dietary supplement | VD3 group |
| omega 3 FA groupomega 3 FA group 300 mg once daily for 8 weeks | Dietary supplement | omega 3- FA group |
| VD3 and omega- 3FA group50000 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 |
| control groupno intervention was given | Other | control group |
Primary outcome
VD 3
Time frame: 8 weeks
Serum level of 25-hydroxyvitamin D
leptin
Time frame: 8 weeks
serum level of leptin
HbA1C
Time frame: 8 weeks
plasma concentration of HbA1C
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 17 Jul 2019.
- Results publication: PubMed 21492489Ross AC. The 2011 report on dietary reference intakes for calcium and vitamin D. Public Health Nutr. 2011 May;14(5):938-9. doi: 10.1017/S1368980011000565. No abstract available.
- 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
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 group, omega 3 FA group and VD3 and omega- 3FA group 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 3 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 17 Jul 2019. 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 3 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 NCT03735303, 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 17 Jul 2019.