DIABETES MELLITUSPhase 4VD2000NCT01854463
The Effect of Vitamin D Supplementation in Type 2 Diabetes
A Phase 4 study testing Vitamin D3 in people with DIABETES MELLITUS, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
Trial summary
In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 69 years
- Conditions the study is for
- DIABETES MELLITUS
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Feb 2013
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TYPE 2 DIABETES MELLITUS PATIENTS WHO CONTROL GLUCOSE BY ORAL ANTIBIABETIC DRUGS OR LIFESTYLE ONLY
- DID NOT CHANGE ANTIDIABETIC DRUG BEFORE THE STUDY FOR 2 MONTHS
- normal physical activity
- 30 to 69 years
- >=6.5% OR <8.0% OF HbA1c
Who cannot join
- Creatinine>1.5 in men, >1.4 in women
- heavy alcoholics
- who took calcium or vitamin d or anti-osteoporosis drug within 3 months before the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 200704
About this study
Official title: The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes
In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes.
Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2 diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and bone turnover markers.
Read the detailed description
After informed consent, investigators randomized 180 type 2 diabetes into interventiona group (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental calcium 200mg per day). The participants should control diabetes by oral medications or lifestyle intervention at the intervention period. Investigators exclude the participants who took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal insufficiency (Cr>1.5 in men or Cr>1.4 in women) or heavy alcoholics.
Investigators followed the participants for 24 weeks. After randomization, investigators checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, and aortic augmentation index, and precontrast liver computed tomography. Also investigators checked body weight, height, and peripheral blood pressure.
At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and creatinine.
At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT, Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, aortic augmentation index, and precontrast liver computed tomography.
After the study completed, investiators compared the data of interventional groups and placebo groups.
- Conditions
- DIABETES MELLITUS
- Being tested
- Vitamin D3, placebo
- Keywords
- DIABETES MELLITUS, VITAMIN D, ARTERIAL STIFFNESS, FATTY LIVER, BONE TURNOVER
- Medical subject headings
- Diabetes Mellitus, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called dicamax d
2000IU per day
placeboDrug
Also called calcium
elemental calcium 200mg per day per 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | 25-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks Receives: Drug: Vitamin D3 |
| placebo | Placebo comparator | administered elemental calcium 200mg daily for 24 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
Measured: 0, 12week, and 24week
Secondary outcomes (1)
arterial stiffenss
central blood pressure brachial-ankle pulse wave velocity aortic augmentation index
Measured: at 0 and 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionFeb 2013
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chuncheon Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Diabetes Association
- Responsible party
- Principal investigator, OHKHYUN RYU, Chuncheon Sacred Heart Hospital
- Investigators
- OHKHYUN RYU, PROFESSOR, Principal investigator, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854463
- Sponsor's protocol ID
- CSHH2011-64
- Other IDs
- KDA2010
- Acronym
- VD2000
- Status last verified
- May 2013
- First submitted
- 19 Apr 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Breslavsky A, Frand J, Matas Z, Boaz M, Barnea Z, Shargorodsky M. Effect of high doses of vitamin D on arterial properties, adiponectin, leptin and glucose homeostasis in type 2 diabetic patients. Clin Nutr. 2013 Dec;32(6):970-5. doi: 10.1016/j.clnu.2013.01.020. Epub 2013 Feb 27.
PubMed 23561637
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on the Glycemic Control and Non-alcoholic Fatty Liver Disease in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01854463
- Acronym / sponsor ID
- VD2000 / CSHH2011-64
- Conditions
- DIABETES MELLITUS
- Keywords
- DIABETES MELLITUS, VITAMIN D, ARTERIAL STIFFNESS, FATTY LIVER, BONE TURNOVER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Chuncheon Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Korean Diabetes Association
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 May 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.
In many observational studies, vitamin D deficiency is related to glucose intolerance and diabetes. But there little randomized, controlled interventional studies that evaluate the effect of vitamin D in type 2 diabetes.
Investigators investigate the effect of high dose (2000IU) 25-hydroxy vitamin D on type 2 diabetes in glycemic controls, non-alcholic fatty liver disease, and arterial stiffness, and bone turnover markers.
Detailed description
After informed consent, investigators randomized 180 type 2 diabetes into interventiona group (25-hydroxy vitamin d 2000 IU+ elemental calcium 200mg per day) or placebo group (elemental calcium 200mg per day). The participants should control diabetes by oral medications or lifestyle intervention at the intervention period. Investigators exclude the participants who took vitamin D or calcium or anti-osteoporotic drugs. Investigators also exclude renal insufficiency (Cr>1.5 in men or Cr>1.4 in women) or heavy alcoholics.
Investigators followed the participants for 24 weeks. After randomization, investigators checked HbA1c,glucose, calcium, 25-hydroxyvitamin d, AST, ALT,Creatinine, Parathyroid hormone, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, and aortic augmentation index, and precontrast liver computed tomography. Also investigators checked body weight, height, and peripheral blood pressure.
At 12 weeks, investigators checked HbA1c, 25-hydroxy vitamin D, AST, ALT, calcium, and creatinine.
At the end of the study(at 24 weeks), investigators checked HbA1c, glucose, AST, ALT, Creatinine, calcium, bone-specific alkaline phosphatase, serum CTX, brachial-ankle pulse wave velocity, central blood pressure, aortic augmentation index, and precontrast liver computed tomography.
After the study completed, investiators compared the data of interventional groups and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D325-hydroxy vitamin d 2000 IU and elemeental calcium 200mg daily for 24 weeks |
| placebo | Placebo comparator | Drug: placeboadministered elemental calcium 200mg daily for 24 weeks |
Who may qualify
- Ages
- 30 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TYPE 2 DIABETES MELLITUS PATIENTS WHO CONTROL GLUCOSE BY ORAL ANTIBIABETIC DRUGS OR LIFESTYLE ONLY
- DID NOT CHANGE ANTIDIABETIC DRUG BEFORE THE STUDY FOR 2 MONTHS
- normal physical activity
- 30 to 69 years
- >=6.5% OR <8.0% OF HbA1c
Key exclusion criteria (3 listed)
- Creatinine>1.5 in men, >1.4 in women
- heavy alcoholics
- who took calcium or vitamin d or anti-osteoporosis drug within 3 months before the study
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 D3Also: dicamax d2000IU per day | Drug | Vitamin D3 |
| placeboAlso: calciumelemental calcium 200mg per day per 24 weeks | Drug | placebo |
Primary outcome
glycemic control
Time frame: 0, 12week, and 24week
Investigators checked glycemic control status at the enrollment, 12-week, 24- week by HbA1c
1 secondary outcome
arterial stiffenss
Time frame: at 0 and 24-week
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 15 May 2013.
- Background: PubMed 23561637Breslavsky A, Frand J, Matas Z, Boaz M, Barnea Z, Shargorodsky M. Effect of high doses of vitamin D on arterial properties, adiponectin, leptin and glucose homeostasis in type 2 diabetic patients. Clin Nutr. 2013 Dec;32(6):970-5. doi: 10.1016/j.clnu.2013.01.020. Epub 2013 Feb 27.
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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.
OHKHYUN RYU, PROFESSOR principal investigator
Hallym University Medical Center
1 site 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 D3 in people with DIABETES MELLITUS, run by Chuncheon Sacred Heart Hospital at 1 site in South Korea.
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 5 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 15 May 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 South Korea. 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?
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?
glycemic control (time frame: 0, 12week, and 24week). 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 NCT01854463, 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 15 May 2013.