Type 2 Diabetes MellitusNCT00985361
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
A study testing Vitamin D3 2000 international units daily and Vitamin C 500mg daily in people with Type 2 Diabetes Mellitus, run by ProMedica Health System at 3 sites in United States.
Trial summary
The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vitamin D3 2000 international units daily and Vitamin C 500mg daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to Mar 2010
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Hemoglobin A1c >7% measured in the 3 months prior to randomization
- Age 21 to 75 years
Who cannot join
- Renal insufficiency (defined as CrCl <30mL/min)
- Gestational diabetes
- Malabsorption syndrome
- Patients taking vitamin D supplements at doses >400 international units daily
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Flower Hospital Family Medicine Residency
Sylvania, Ohio, 43560
Center for Health Services
Toledo, Ohio, 43606
Toledo Hospital Family Medicine Residency
Toledo, Ohio, 43606
About this study
The purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.
Read the detailed description
Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vitamin D3 2000 international units daily, Vitamin C 500mg daily
- 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 D3 2000 international units dailyDietary supplement
Vitamin D3 2000 international unit tablets once daily for 3 months
Vitamin C 500mg dailyDietary supplement
Vitamin C 500mg tablets once daily for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 2000 international units daily | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 2000 international units daily |
| Vitamin C 500mg daily | Active comparator | Not described Receives: Dietary Supplement: Vitamin C 500mg daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
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 posted28 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Investigators
- Mate M Soric, PharmD, Principal investigator, ProMedica Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985361
- Sponsor's protocol ID
- 09-055
- Status last verified
- Oct 2009
- First submitted
- 25 Sep 2009
- Last updated
- 6 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Soric MM, Renner ET, Smith SR. Effect of daily vitamin D supplementation on HbA1c in patients with uncontrolled type 2 diabetes mellitus: a pilot study. J Diabetes. 2012 Mar;4(1):104-5. doi: 10.1111/j.1753-0407.2011.00164.x. No abstract available.
PubMed 22018074
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00985361
- Acronym / sponsor ID
- 09-055
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Sep 2009 (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 purpose of this study is to determine if daily supplementation with 2000 International Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.
Detailed description
Vitamin D is typically understood to support musculoskeletal health when administered concomitantly with calcium. A number of recent studies suggest, however, that this important nutrient may play a significant role in many pathophysiological processes, including diabetes mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and debilitating complications of this chronic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 2000 international units daily | Experimental | Dietary Supplement: Vitamin D3 2000 international units daily |
| Vitamin C 500mg daily | Active comparator | Dietary Supplement: Vitamin C 500mg daily |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Hemoglobin A1c >7% measured in the 3 months prior to randomization
- Age 21 to 75 years
Key exclusion criteria (4 listed)
- Renal insufficiency (defined as CrCl <30mL/min)
- Gestational diabetes
- Malabsorption syndrome
- Patients taking vitamin D supplements at doses >400 international units daily
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 D3 2000 international units dailyVitamin D3 2000 international unit tablets once daily for 3 months | Dietary supplement | Vitamin D 2000 international units daily |
| Vitamin C 500mg dailyVitamin C 500mg tablets once daily for 3 months | Dietary supplement | Vitamin C 500mg daily |
Primary outcome
Hemoglobin A1c
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 6 May 2010.
- Derived from this study: PubMed 22018074Soric MM, Renner ET, Smith SR. Effect of daily vitamin D supplementation on HbA1c in patients with uncontrolled type 2 diabetes mellitus: a pilot study. J Diabetes. 2012 Mar;4(1):104-5. doi: 10.1111/j.1753-0407.2011.00164.x. No abstract available.
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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.
Mate M Soric, PharmD principal investigator
ProMedica Health System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 2000 international units daily and Vitamin C 500mg daily in people with Type 2 Diabetes Mellitus, run by ProMedica Health System at 3 sites in United States.
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 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 6 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Hemoglobin A1c (time frame: 3 months). 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 NCT00985361, 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 6 May 2010.