Type 2 Diabetes MellitusPhase 1NCT02464462
The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity
A Phase 1 study testing vitamin D3 and calcium in people with Type 2 Diabetes Mellitus, run by York University.
Trial summary
The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- vitamin D3 and calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Dec 2013
- 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Non-white, post menopausal female
- Have access to Community Health Center
Who cannot join
- neurodegenerative disease
- kideny disease
- gluten allergy
About this study
Official title: The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus
The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.
Read the detailed description
Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- vitamin D3 and calcium, Placebo
- Keywords
- serum calcidiol, T2DM, vitamin D3 supplementation, post-menopausal women, ethnic diverse, calcium supplementation
- 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 and calciumDietary supplement
1800 IU vitamin D3 plus 720 mg Calcium
PlaceboOther
Rice powder pills
| Study group | Role | What they receive |
|---|---|---|
| CaD Group | Experimental | This arm received total of 1800 IU of vitamin D3 and 720 mg of calcium Receives: Dietary Supplement: vitamin D3 and calcium |
| Placebo Group | Placebo comparator | This arm received rice powder pills Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calcidiol
Measured: 3 years
Secondary outcomes (4)
Fasting insulin
Measured: 3 years
Parathyroid Hormone
Measured: 3 years
Fasting blood glucose
Measured: 3 years
Glycated Hemoglobin
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2010
- Primary completionAug 2013
- Study completionDec 2013
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health in Women's Hands Community Health Center
- Responsible party
- Principal investigator, MAZEN J HAMADEH, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464462
- Sponsor's protocol ID
- 220
- Other IDs
- STU 2013-024
- Status last verified
- Jun 2015
- First submitted
- 3 Jun 2015
- Last updated
- 8 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Vitamin D and Calcium Supplementation in the Pathogenesis of Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02464462
- Acronym / sponsor ID
- 220
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- serum calcidiol, T2DM, vitamin D3 supplementation, post-menopausal women, ethnic diverse, calcium supplementation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Women's Health in Women's Hands Community Health Center
- Study start
- May 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Jun 2015 (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 investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.
Detailed description
Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaD Group | Experimental | Dietary Supplement: vitamin D3 and calciumThis arm received total of 1800 IU of vitamin D3 and 720 mg of calcium |
| Placebo Group | Placebo comparator | Other: PlaceboThis arm received rice powder pills |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Non-white, post menopausal female
- Have access to Community Health Center
Key exclusion criteria (3 listed)
- neurodegenerative disease
- kideny disease
- gluten allergy
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 and calcium1800 IU vitamin D3 plus 720 mg Calcium | Dietary supplement | CaD Group |
| PlaceboRice powder pills | Other | Placebo Group |
Primary outcome
Serum calcidiol
Time frame: 3 years
4 secondary outcomes
Fasting insulin
Time frame: 3 years
Parathyroid Hormone
Time frame: 3 years
Fasting blood glucose
Time frame: 3 years
Glycated Hemoglobin
Time frame: 3 years
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 8 Jun 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vitamin D3 and calcium in people with Type 2 Diabetes Mellitus, run by York University.
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 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
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?
Serum calcidiol (time frame: 3 years). 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 8 Jun 2015.