Type 2 DiabetesPhase 4NCT01876563
the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes
A Phase 4 study testing vitamin D in people with Type 2 Diabetes, run by Tehran University of Medical Sciences at 2 sites in Iran.
Trial summary
The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesIran
- Study dates
- Aug 2012to Jul 2014
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -
Who cannot join
- people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers
- -
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Tehran University of Medical Sciences
Tehran, Tehran Province
Tehran University of Medical Sciences
Tehran
About this study
The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes
- Conditions
- Type 2 Diabetes
- Being tested
- vitamin D, placebo
- Keywords
- thioredoxin, TBP-2, thioredoxin reductase, vitamin D, DIABETES
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin DDietary supplement
one tab 4000 IU/day vitamin D
placeboDietary supplement
one tab per day placebo
| Study group | Role | What they receive |
|---|---|---|
| diabetes, vitamin D | Active comparator | patients with type 2 diabetes who receive 4000 IU/day vitamin D Receives: Dietary Supplement: vitamin D |
| placebo, diabetes | Placebo comparator | patients with type 2 diabetes who receive one tab placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum total cholesterol
Measured: change from baseline at 2 months
serum HDL cholesterol
Measured: change from baseline at 2 months
serum triglycerides level
Measured: change from baseline at 2 months
fasting plasma glucose
Measured: change from baseline at 2 months
serum LDL cholesterol
Measured: change from baseline at 2 months
complete blood count (CBC)
Measured: change from baseline at 2 months
HbA1c
Measured: change from baseline at 2 months
serum insulin
Measured: change from baseline at 2 months
serum calcidiol
Measured: change from baseline at 2 months
thioredoxin
Measured: change from baseline at 2 months
thioredoxin binding protein 2 (TBP-2)
Measured: change from baseline at 2 months
erytrocyte thioredoxin reductase
Measured: change from baseline at 2 months
Secondary outcomes (1)
GENE EXPRESSION OF TBP-2
Measured: change from baseline at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionFeb 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876563
- Sponsor's protocol ID
- 17112
- Status last verified
- Jun 2013
- First submitted
- 10 Jun 2013
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Vitamin D on the Serum Thioredoxin, TBP-2, Thioredoxin Reductase, Gene Expression of TBP-2 in Patients With Type II Diabetes
- ClinicalTrials.gov ID
- NCT01876563
- Acronym / sponsor ID
- 17112
- Conditions
- Type 2 Diabetes
- Keywords
- thioredoxin, TBP-2, thioredoxin reductase, vitamin D, DIABETES
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 12 Jun 2013 (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.
The aim of this study is the comparision between the effects of vitamin D or placebo supplementation for 2 months in serum level of thioredoxin, TBP-2 and thioredoxin reductase activity in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes, vitamin D | Active comparator | Dietary Supplement: vitamin Dpatients with type 2 diabetes who receive 4000 IU/day vitamin D |
| placebo, diabetes | Placebo comparator | Dietary Supplement: placebopatients with type 2 diabetes who receive one tab placebo |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- literate, willingness to participation, diabetic patients 30- 60 years old, body mass index in the range 18.5- 35, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention -
Key exclusion criteria (2 listed)
- people who have used vitamin D supplements in last 3 months, having chronic renal disease , GI disease, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, treatment with orlistat or sibutramine for weight loss, pregnancy and lactation, treatment with insulin or Thiazolidinediones, Smokers
- -
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 Done tab 4000 IU/day vitamin D | Dietary supplement | diabetes, vitamin D |
| placeboone tab per day placebo | Dietary supplement | placebo, diabetes |
Primary outcome
serum total cholesterol
Time frame: change from baseline at 2 months
serum HDL cholesterol
Time frame: change from baseline at 2 months
serum triglycerides level
Time frame: change from baseline at 2 months
fasting plasma glucose
Time frame: change from baseline at 2 months
serum LDL cholesterol
Time frame: change from baseline at 2 months
complete blood count (CBC)
Time frame: change from baseline at 2 months
HbA1c
Time frame: change from baseline at 2 months
serum insulin
Time frame: change from baseline at 2 months
serum calcidiol
Time frame: change from baseline at 2 months
thioredoxin
Time frame: change from baseline at 2 months
thioredoxin binding protein 2 (TBP-2)
Time frame: change from baseline at 2 months
erytrocyte thioredoxin reductase
Time frame: change from baseline at 2 months
1 secondary outcome
GENE EXPRESSION OF TBP-2
Time frame: change from baseline at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing vitamin D in people with Type 2 Diabetes, run by Tehran University of Medical Sciences at 2 sites in Iran.
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 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: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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. 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?
Results are not available in the source record.
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 total cholesterol (time frame: change from baseline at 2 months). The study lists 12 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 12 Jun 2013.