Type 2 Diabetes MellitusPhase 1Vit CNCT01319734
Vitamin C Supplementation Plus Hypoglycemic Agents Versus Hypoglycemic Agents Alone in Type 2 Diabetes Mellitus
A Phase 1 study testing Vitamin C and glyburide in people with Type 2 Diabetes Mellitus, run by Al-Neelain University at 1 site in Sudan.
Trial summary
Null hypothesis: No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM). Alternative hypothesis: There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vitamin C and glyburide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSudan
- Study dates
- Feb 2011to Dec 2015
- Phase
- Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of type 2DM
- patients in good health
- receiving oral hypoglycemic drugs
Who cannot join
- Insulin dependent diabetes
- receiving vitamin complex
- smoking
- renal disease
- liver disease
Trial locations and contacts
1 site in 1 country.
Maha I Mohammed, MBBS, PhD contact
Sudan1 site, 1 recruiting
- Recruiting
Jaber abo aliz
Khartoum, Khartoum State, 1111
Khaled H Bakheet, MD,PhD, +249912957764, khalid2_3456@yahoo.com
Hamdan Z Hamdan, MBBS,MSc
About this study
Official title: Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications
Null hypothesis:
No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).
Alternative hypothesis:
There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vitamin C, glyburide
- Keywords
- Vitamin C, Oxidative stress, Type 2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Vitamin C supplementation 500mg
glyburideDrug
this group receiving glyburide 5 mg alone
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C supplementation plus oral hypoglycemic agents arm | Experimental | This group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients. Receives: Dietary Supplement: Vitamin C |
| Type 2DM patients receiving oral hypoglycemic agents alone | Active comparator | this group is the control group who receive oral hypoglycemic agents alone Receives: Drug: glyburide |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving the renal function
vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
Measured: the renal function will be measure at day 1 and after one month
Secondary outcomes (1)
Vitamin C can improve the visual fields
the damage of the eye can be prevented by decreasing the oxidative stress in the eye, this can be accomplished by vitamin C.
Measured: the visual field will be assesed at day 1 and after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Neelain University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdan Zaki Hamdan, Al-Neelain University
- Investigators
- Hamdan Z Hamdan, MBBS, MSc, Principal investigator, Al-Neelain University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319734
- Sponsor's protocol ID
- 22
- Acronym
- Vit C
- Status last verified
- Sep 2013
- First submitted
- 21 Mar 2011
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Randomized Clinical Trial Comparing Vitamin C Supplementation Plus Oral Hypoglycemic Drugs Versus Hypoglycemic Drugs Alone on Serum Selenium, Zinc, Copper and Malondialdehyde Levels in Type 2 Diabetes Mellitus and Its Microvascular Complications
- ClinicalTrials.gov ID
- NCT01319734
- Acronym / sponsor ID
- Vit C / 22
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Vitamin C, Oxidative stress, Type 2DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Al-Neelain UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 22 Mar 2011 (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.
Null hypothesis:
No significant effect of vitamin C 500 mg Supplementation on the severity of micro-vascular complications of type 2 Diabetes Mellitus (DM).
Alternative hypothesis:
There is a significant effect of vitamin C 500mg supplementation on the severity of the micro-vascular complications of type 2DM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C supplementation plus oral hypoglycemic agents arm | Experimental | Dietary Supplement: Vitamin CThis group will receive vitamin C supplementation 500mg daily for one month and then assessment will done for the patients. |
| Type 2DM patients receiving oral hypoglycemic agents alone | Active comparator | Drug: glyburidethis group is the control group who receive oral hypoglycemic agents alone |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of type 2DM
- patients in good health
- receiving oral hypoglycemic drugs
Key exclusion criteria (5 listed)
- Insulin dependent diabetes
- receiving vitamin complex
- smoking
- renal disease
- liver 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 |
|---|---|---|
| Vitamin CVitamin C supplementation 500mg | Dietary supplement | Vitamin C supplementation plus oral hypoglycemic agents arm |
| glyburidethis group receiving glyburide 5 mg alone | Drug | Type 2DM patients receiving oral hypoglycemic agents alone |
Primary outcome
improving the renal function
Time frame: the renal function will be measure at day 1 and after one month
vitamin c supplementation act as an antioxidants which reduce the oxidative stress and then can improve the renal function.
1 secondary outcome
Vitamin C can improve the visual fields
Time frame: the visual field will be assesed at day 1 and after one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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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.
Maha I Mohammed, MBBS, PhD contact
Hamdan Z Hamdan, MBBS, MSc principal investigator
Al-Neelain University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin C and glyburide in people with Type 2 Diabetes Mellitus, run by Al-Neelain University at 1 site in Sudan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Sep 2013. 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 Sudan. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamdan Z Hamdan, MBBS, Msc (+249912468264, hamdanology@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improving the renal function (time frame: the renal function will be measure at day 1 and after one month). 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 18 Sep 2013.