Diabetes Mellitus, Type 2NCT04439474
Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
A study testing Vitamin D3 and Routine treatment in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Vitamin D3 and Routine treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteIran
- Study dates
- 10 Oct 2018to 10 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes
- Having conscious satisfaction
Who cannot join
- Patients with a history of gastrointestinal surgery
- Patients with a history of renal failure
- Patients with a history of vitamin D intake and calcium-containing compounds
- Patients with a history of liver disease
Trial locations and contacts
1 site in 1 country.
About this study
This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. One group included participants with vitamin D deficiency and the other group did not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Vitamin D3, Routine treatment
- 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 D3Drug
For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml.
Routine treatmentDrug
In this group, patients receive their usual medications and treatments
| Study group | Role | What they receive |
|---|---|---|
| Patients with vitamin D deficiency | Experimental | This group receives 50,000 units of vitamin D3 daily for up to 8 days until the serum level of vitamin D reaches above 30 ng/ml. Receives: Drug: Vitamin D3 |
| Patients without vitamin D deficiency | Active comparator | Participants in this group receive only their usual treatments Receives: Drug: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D serum levels
Vitamin D serum levels measured by blood tests
Measured: up to 1 year
Triglyceride
Level of blood triglycerides measured by a blood test
Measured: up to 1 year
Blood cholesterol levels
Blood cholesterol levels measured by a blood test
Measured: up to 1 year
HDL
Blood HDL levels measured by a blood test
Measured: up to 1 year
LDL
Blood LDL levels measured by a blood test
Measured: up to 1 year
Fasting blood glucose
Fasting blood glucose levels measured by a blood test
Measured: up to 1 year
Neuropathy
Neuropathy based on United Kingdom Screening TEST
Measured: up to 1 year
Nephropathy
Nephropathy based on albumin excretion evaluation
Measured: up to 1 year
Retinopathy
Retinopathy based on an ophthalmologist's examination
Measured: up to 1 year
blood pressure
Systolic and diastolic blood pressure measured by Sphygmomanometer
Measured: up to 1 year
HBA1C
Blood sugar levels measured in the last three months measured by blood test
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start10 Oct 2018
- Primary completion10 Nov 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439474
- Sponsor's protocol ID
- IR.BMSU.REC.1392.32
- Status last verified
- Jun 2020
- First submitted
- 17 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Vitamin D, Dyslipidemia and Microvascular in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04439474
- Acronym / sponsor ID
- IR.BMSU.REC.1392.32
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 19 Jun 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.
This study looked at the effect of vitamin D levels on the complications of type 2 diabetes and the fat profile of patients with diabetes.Participants in this study were divided into two groups. One group included participants with vitamin D deficiency and the other group did not.The first group receives 50,000 units of oral vitamin D 3 daily for up to 8 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with vitamin D deficiency | Experimental | Drug: Vitamin D3This group receives 50,000 units of vitamin D3 daily for up to 8 days until the serum level of vitamin D reaches above 30 ng/ml. |
| Patients without vitamin D deficiency | Active comparator | Drug: Routine treatmentParticipants in this group receive only their usual treatments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes
- Having conscious satisfaction
Key exclusion criteria (4 listed)
- Patients with a history of gastrointestinal surgery
- Patients with a history of renal failure
- Patients with a history of vitamin D intake and calcium-containing compounds
- Patients with a history of 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 D3For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml. | Drug | Patients with vitamin D deficiency |
| Routine treatmentIn this group, patients receive their usual medications and treatments | Drug | Patients without vitamin D deficiency |
Primary outcome
Vitamin D serum levels
Time frame: up to 1 year
Vitamin D serum levels measured by blood tests
Triglyceride
Time frame: up to 1 year
Level of blood triglycerides measured by a blood test
Blood cholesterol levels
Time frame: up to 1 year
Blood cholesterol levels measured by a blood test
HDL
Time frame: up to 1 year
Blood HDL levels measured by a blood test
LDL
Time frame: up to 1 year
Blood LDL levels measured by a blood test
Fasting blood glucose
Time frame: up to 1 year
Fasting blood glucose levels measured by a blood test
Neuropathy
Time frame: up to 1 year
Neuropathy based on United Kingdom Screening TEST
Nephropathy
Time frame: up to 1 year
Nephropathy based on albumin excretion evaluation
Retinopathy
Time frame: up to 1 year
Retinopathy based on an ophthalmologist's examination
blood pressure
Time frame: up to 1 year
Systolic and diastolic blood pressure measured by Sphygmomanometer
HBA1C
Time frame: up to 1 year
Blood sugar levels measured in the last three months measured by blood test
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 19 Jun 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Routine treatment in people with Diabetes Mellitus, Type 2, run by Baqiyatallah Medical Sciences University at 1 site 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 2 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 19 Jun 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 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. 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?
Vitamin D serum levels (time frame: up to 1 year). The study lists 11 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 19 Jun 2020.