Type 2 Diabetes MellitusPhase 3NCT01170468
Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals
A Phase 3 study testing Vitamin D3 in people with Type 2 Diabetes Mellitus, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Dec 2011to 15 Jan 2014
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
- Who consume no more than one serving of milk/day
- Do not take vitamin supplement
- Habitually have less than 10 hour of sun exposure per week
- Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
- Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
About this study
Official title: Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial
Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.
The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vitamin D3, Placebo
- Keywords
- Prediabetics, DM, vitamin D
- 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
Also called cholecalciferol
Vitamin D3 5000 IU orally, daily for 2 years
PlaceboDrug
Placebo orally, daily for 2 years
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Vitamin D3 5000 IU daily Receives: Drug: Vitamin D3 |
| Placebo | Placebo comparator | Placebo daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of DM
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
Measured: 2 years
Secondary outcomes (9)
slope of fasting glucose level
Measured: 2 years
slope of 2-hour post challenge glucose level
Measured: 2 years
area under the curve of BP
Measured: 2 years
area under the curve of weight
Measured: 2 years
area under the curve of 25 OH vitamin D level
Measured: 2 years
fasting insulin to glucose ratio
Measured: 2 years
incidence of hypercalcemia
Measured: 2 years
incidence of hypercalciuria
Measured: 2 years
time to develop DM
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startDec 2011
- Primary completion15 Jan 2014
- Study completion15 Jan 2014
Why it stopped: inadequate enrollement
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Maher Hammami, King Faisal Specialist Hospital & Research Center
- Investigators
- Muhammad M Hammami, MD, PhD, Principal investigator, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170468
- Sponsor's protocol ID
- RAC 2101040
- Status last verified
- Mar 2018
- First submitted
- 25 Jul 2010
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01170468
- Acronym / sponsor ID
- RAC 2101040
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Prediabetics, DM, vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollement
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- 15 Jan 2014 (actual)
- Study completion
- 15 Jan 2014 (actual)
- First posted
- 27 Jul 2010 (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.
Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established.
The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3Vitamin D3 5000 IU daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l
- Who consume no more than one serving of milk/day
- Do not take vitamin supplement
- Habitually have less than 10 hour of sun exposure per week
- Don't suffer from granulomatus conditions, liver disease, kidney disease, or diabetes
Key exclusion criteria (0 listed)
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: cholecalciferolVitamin D3 5000 IU orally, daily for 2 years | Drug | Vitamin D3 |
| PlaceboPlacebo orally, daily for 2 years | Drug | Placebo |
Primary outcome
The incidence of DM
Time frame: 2 years
Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
9 secondary outcomes
slope of fasting glucose level
Time frame: 2 years
slope of 2-hour post challenge glucose level
Time frame: 2 years
area under the curve of BP
Time frame: 2 years
area under the curve of weight
Time frame: 2 years
area under the curve of 25 OH vitamin D level
Time frame: 2 years
fasting insulin to glucose ratio
Time frame: 2 years
incidence of hypercalcemia
Time frame: 2 years
incidence of hypercalciuria
Time frame: 2 years
time to develop DM
Time frame: 2 years
Results and safety
The study was stopped early (reason given: inadequate enrollement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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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.
Muhammad M Hammami, MD, PhD principal investigator
King Faisal Specialist Hospital & Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 in people with Type 2 Diabetes Mellitus, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 6 inclusion and 0 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: stopped early, as of the sponsor's last update on 7 Mar 2018. 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 Saudi Arabia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: inadequate enrollement). 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?
The incidence of DM (time frame: 2 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 7 Mar 2018.