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Diabetes MellitusPhase 3NCT01170442

Does Vitamin D Improve Glycemic Control in Type II DM?

A Phase 3 study testing vitamin D3 2000 IU and vitamin D3 5000 IU in people with Diabetes Mellitus and Vitamin D Deficiency, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Diabetes Mellitus, Vitamin D Deficiency
What is being tested?
vitamin D3 2000 IU and vitamin D3 5000 IU
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 Dec 2013
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

  • Type II diabetics living in Riyadh area 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 granulomatous conditions, liver disease, or kidney disease
  • Don't take anticonvulsants, barbiturates, or steroids.
  • Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier)
  • Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.

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

Other trials in Saudi Arabia

About this study

Official title: Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.

Being tested
vitamin D3 2000 IU, vitamin D3 5000 IU, Placebo
Medical subject headings
Diabetes Mellitus, Vitamin D Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vitamin D3 2000 IUDrug

    Also called cholecalciferol

    vitamin D3 2000 IU orally, daily for 6 months

  • vitamin D3 5000 IUDrug

    Also called cholecalciferol

    vitamin D3 5000 IU orally, daily for 6 months

  • PlaceboDrug

    placebo orally, daily for six months

Study groups in NCT01170442
Study groupRoleWhat they receive
vitamin D3 2000 IUExperimentalNot described
Receives: Drug: vitamin D3 2000 IU
vitamin D3 5000 IUExperimentalNot described
Receives: Drug: vitamin D3 5000 IU
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve of HA1C.

    Measured: 6 months

Secondary outcomes (8)

  1. Area under the curve for BP

    Measured: 6 months

  2. area under the curve of weight

    Measured: 6 months

  3. area under the curve for 25 OH vitamin D level

    Measured: 6 months

  4. area under the curve of fasting blood glucose

    Measured: 6 months

  5. area under the curve of 2 hour post breakfast glucose

    Measured: 6 months

  6. fasting insulin to glucose ratio

    Measured: 6 months

  7. incidence of hypercalcemia

    Measured: 6 months

  8. incidence of hypercalciuria

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2010 (estimated)
  2. Study startDec 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

Why it stopped: In adequate enrollment

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01170442
Sponsor's protocol ID
RAC 2101039
Status last verified
Mar 2015
First submitted
25 Jul 2010
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vitamin D3 2000 IU and vitamin D3 5000 IU in people with Diabetes Mellitus and Vitamin D Deficiency, 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 7 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 1 Apr 2015. 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: In adequate enrollment). 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?

Area under the curve of HA1C. (time frame: 6 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 NCT01170442.

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 1 Apr 2015.

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