DiabetesPhase 4NCT01691365
Effects of Antioxidants and B Vitamins Supplements on Inflammation in Obese Diabetic Patients
A Phase 4 study testing vitamins in people with Diabetes and Obesity, run by United Arab Emirates University.
Trial summary
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Jun 2011
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes mellitus
Who cannot join
- severe chronic clinical or psychiatric disease,
- participating in other intervention trials,
- on dietary supplements and
- those unable to give an informed written consent
About this study
Official title: Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit
Read the detailed description
Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins [800 IU (727mg) of a-tocopherol and 500mg of vitamin C] [n=48], or no supplements [n= 48] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis.
Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.
- Being tested
- vitamins, Placebo
- Keywords
- Antioxidant, vitamins, Diet
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitaminsDietary supplement
Also called Antioxidants, B vitamins
a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days
PlaceboDrug
Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
| Study group | Role | What they receive |
|---|---|---|
| vitamins pills | Active comparator | antioxidant and B vitamins vitamins vitamin
-------------------------------------------------------------------------------- Receives: Dietary Supplement: vitamins |
| pills | Placebo comparator | MICROCRYSTALLINE CELLULOSE Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Measured: 3 months
Oxidative damage
Measured: 3 months
Secondary outcomes (1)
Antioxidant status
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionJun 2011
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 DiabetesStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Collaborators
- Tawam Hospital
- Responsible party
- Principal investigator, Salah Gariballa, United Arab Emirates University
- Investigators
- Salah Gariballa, MD, Principal investigator, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691365
- Sponsor's protocol ID
- FMHS
- Status last verified
- Sep 2012
- First submitted
- 11 Sep 2012
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gariballa S, Alkaabi J, Yasin J, Al Essa A. Total adiponectin in overweight and obese subjects and its response to visceral fat loss. BMC Endocr Disord. 2019 Jun 3;19(1):55. doi: 10.1186/s12902-019-0386-z.
PubMed 31159801
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
- ClinicalTrials.gov ID
- NCT01691365
- Acronym / sponsor ID
- FMHS
- Keywords
- Antioxidant, vitamins, Diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Collaborators
- Tawam Hospital
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Sep 2012 (estimated)
- 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.
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit
Detailed description
Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins [800 IU (727mg) of a-tocopherol and 500mg of vitamin C] [n=48], or no supplements [n= 48] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis.
Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamins pills | Active comparator | Dietary Supplement: vitaminsantioxidant and B vitamins vitamins vitamin -------------------------------------------------------------------------------- |
| pills | Placebo comparator | Drug: PlaceboMICROCRYSTALLINE CELLULOSE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 Diabetes mellitus
Key exclusion criteria (4 listed)
- severe chronic clinical or psychiatric disease,
- participating in other intervention trials,
- on dietary supplements and
- those unable to give an informed written consent
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 |
|---|---|---|
| vitaminsAlso: Antioxidants, B vitaminsa capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days | Dietary supplement | vitamins pills |
| PlaceboPlacebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide) | Drug | pills |
Primary outcome
Inflammation
Time frame: 3 months
Oxidative damage
Time frame: 3 months
1 secondary outcome
Antioxidant status
Time frame: 3 months
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 Sep 2012.
- Derived from this study: PubMed 31159801Gariballa S, Alkaabi J, Yasin J, Al Essa A. Total adiponectin in overweight and obese subjects and its response to visceral fat loss. BMC Endocr Disord. 2019 Jun 3;19(1):55. doi: 10.1186/s12902-019-0386-z.
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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.
Salah Gariballa, MD principal investigator
United Arab Emirates University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamins in people with Diabetes and Obesity, run by United Arab Emirates University.
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 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 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Inflammation (time frame: 3 months). 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 NCT01691365, 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 24 Sep 2012.